Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-02 @ 3:14 AM
Study NCT ID:
NCT01686958
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2012-09-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Study of MRI-guided Transurethral Ultrasound Ablation of Prostate Tissue to Treat Localized Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mburtnyk@profoundmedical.com', 'phone': '647-476-1350', 'title': 'Mathieu Burtnyk', 'phoneExt': '408', 'organization': 'Profound Medical'}, 'certainAgreement': {'otherDetails': "Sponsor will review the publication text within twenty days of receipt, however, Sponsor can request changes if text contains Sponsor's Confidential Information, or text contains information for which the Sponsor wishes to obtain patent protection, whereupon such information will be removed or there will be a delay to the presentation or publication to enable the Sponsor to proceed with patent application for an additional 60 days or until patent application has been filed, whichever is earlier.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'description': 'Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).', 'eventGroups': [{'id': 'EG000', 'title': 'MR-Guided Transurethral US Ablation', 'description': 'MR-Guided Transurethral US Ablation of Prostate Tissue\n\nMR-Guided Transurethral US Ablation of Prostate Tissue: The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prescribed prostate tissue.', 'otherNumAtRisk': 30, 'otherNumAffected': 30, 'seriousNumAtRisk': 30, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 15}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary stricture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fecal straining', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema: penile and/or scrotal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema: testicular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhagic cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased post void urinary residual in bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Obstructive micturition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Penile discharge or bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostate anatomical change or discoloration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostate inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostate tissue sloughing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Scarred urethra', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urethral skin tags', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary hesitancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary sensation to void', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urine abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erectile dysfunction or worsening erectile function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 11}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ejaculation disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 7}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematospermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Distended abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma or Ecchymosis: Buttock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemtoma or Ecchymosis: Femur', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma or Ecchymosis: Sacral bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Patient movement at onset of treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Raised lump: Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain: Back, hips, shoulder, upon catheter removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain: Bladder, penile, perineal, prostate, urethral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suprapubic Catheter: bleeding around SPC, urine leaking around SPC, blocked SPC, catheter fell out', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Epididymitis', 'notes': 'Patient diagnosed with epididymitis on left side, requiring antibiotics. Shortly thereafter patient developed a fever requiring hospital admission with changes to prescribed antibiotics.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retention', 'notes': 'After removal of suprapubic catheter (SPC) as per protocol, the patient experienced retention and received an urethral catheter, but he continued experiencing retention, hence was hospitalized \\& required a second SPC.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety - Evaluate the Frequency of Treatment Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue', 'description': 'The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.\n\nTreatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'pValueComment': 'Confidence intervals \\[CI\\] will be constructed for outcomes of interest at the alpha=0.05 level of significance, i.e. 95% CI.', 'groupDescription': 'A total of 30 subjects will be accrued to this study and treated with the PAD-105. The sample size is based primarily on feasibility and logistical concerns, however, is sufficiently large to allow the safety objectives to be met. Specifically, with 30 total patients, if no treatment-related grade 4 or 5 adverse events are observed, then a one-sided, 95% confidence interval would have an upper bound of 0.095.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This is a primarily descriptive study, no statistical analysis is planned; however, analyses were performed at the alpha=0.05 level of significance and exact analyses will be used wherever possible.', 'otherAnalysisDescription': 'For continuous outcomes, standard summary statistics will include n, mean, standard deviation, median, minimum and maximum. For categorical data, tables will show n and % of patients.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months from the Treatment Date', 'description': 'All reported adverse events were recorded. The frequency was measured as the number of study participants who experienced a treatment/device related adverse event after receiving treatment delivery with PAD-105, the investigational device.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device.'}, {'type': 'SECONDARY', 'title': 'Feasibility - Evaluate the Effectiveness of the Investigational System to Thermally Coagulate Prostate Tissue Conforming to the Target Volume With a High Degree of Accuracy and Precision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue', 'description': 'The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.\n\nTreatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.'}], 'classes': [{'title': 'Thermal ablation accuracy', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Thermal ablation precision', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On Treatment Date', 'description': 'Conformal thermal coagulation of prostate tissue will be determined quantitatively using measures of targeting accuracy which compare the spatial difference between the target volume and target temperature isotherm determined from MR thermometry images acquired during treatment.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Treatment Efficacy - Biopsy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue', 'description': 'The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.\n\nTreatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.'}], 'classes': [{'categories': [{'title': 'Positive biopsy (clinically significant disease)', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Overall absence of clinically significant disease', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months from the Treatment Date', 'description': 'Evaluate the effectiveness of the treatment to achieve disease control at 12 months based on biopsy results.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient did not complete the 12-month visit, therefore 29 patients were included in this analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Treatment Efficacy - PSA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue', 'description': 'The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.\n\nTreatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.'}], 'classes': [{'title': 'PSA @ Baseline', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '8.0'}]}]}, {'title': 'PSA @ 1 month', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.1'}]}]}, {'title': 'PSA @ 3 months', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '1.7'}]}]}, {'title': 'PSA @ 6 months', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '1.1'}]}]}, {'title': 'PSA @ 12 months', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '1.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'As per the Study Schedule, measured at 1-month, 3-months, 6-months and 12-months from the Treatment Date compared to Baseline', 'description': 'Based on measurements obtained at each study visit, characterize the pattern of PSA response within the first 12 months following treatment in comparison to baseline.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Treatment Efficacy - Quality of Life - Urinary Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue', 'description': 'The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.\n\nTreatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.'}], 'classes': [{'title': 'IPSS @ Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '13'}]}]}, {'title': 'IPSS @ 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 12-months post Treatment', 'description': 'Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, International Prostate Symptom Score (IPSS), which focuses on urinary symptoms.\n\nTotal Score: 0 - 35 0-7 - mildly symptomatic 8-19 - moderately symptomatic 20-35 - severely symptomatic', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient did not complete the 12-month visit questionnaire in its entirety, hence overall number of patients analyzed is 29 versus 30 at baseline.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Treatment Efficacy - Quality of Life - Erectile Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue', 'description': 'The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.\n\nTreatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.'}], 'classes': [{'title': 'IIEF-EF-15 @ Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '28'}]}]}, {'title': 'IIEF-EF-15 @ 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 12-months post Treatment', 'description': 'Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, Erectile Function EF domain of the International Index of Erectile Function (IIEF-15), which focuses on erectile symptoms.\n\nMinimum score value - 0 Maximum score value - 30 A higher score corresponds to a better outcome; lower score indicative of erectile dysfunction', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient did not complete the 12-month visit questionnaire in its entirety, hence overall number of patients analyzed is 29 versus 30 at baseline.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Treatment Efficacy - Quality of Life - Bowel Habits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MR-Guided Transurethral Ultrasound of Prostate Tissue Ablation', 'description': 'The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.\n\nTreatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.'}], 'classes': [{'title': 'UCLA-PCI-SF-BH @ Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '100'}]}]}, {'title': 'UCLA-PCI-SF-BH @ 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 12-months post Treatment', 'description': 'Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, Bowel Habits domain of the UCLA Prostate Cancer Index Short Form (UCLA-PCl-SF-BH), which focuses on bowel symptoms.\n\nMinimum score value - 0 Maximum score value - 100 A higher score corresponds to better outcome', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient did not complete the 12-month visit questionnaire in its entirety, hence overall number of patients analyzed is 29 versus 30 at baseline.'}, {'type': 'PRIMARY', 'title': 'Safety - Evaluate the Severity of Treatment Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue', 'description': 'The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.\n\nTreatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.'}], 'classes': [{'title': 'Hematuria - G1', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '63'}]}]}, {'title': 'Hematuria - G2', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '22'}]}]}, {'title': 'Urinary tract infection - G2', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '53'}]}]}, {'title': 'Epididymitis - G3', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '17'}]}]}, {'title': 'Urinary retention - G1', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '27'}]}]}, {'title': 'Urinary retention - G2', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '35'}]}]}, {'title': 'Obstructive micturition', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '27'}]}]}, {'title': 'Urinary incontinence - G1', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '17'}]}]}, {'title': 'Urinary incontinence - G2', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '27'}]}]}, {'title': 'Urinary stricture - G1', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '17'}]}]}, {'title': 'Urinary stricture - G2', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '17'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months from the Treatment Date', 'description': 'Severity of treatment/device related adverse events were evaluated in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard (version 4), published by the National Cancer Institute (NCI).\n\nThere was no intraoperative complication, no rectal injury or fistula and no severe urinary incontinence. No Grade 4 (G4) or higher adverse events and only one attributable Grade 3 (G3) event; reported below. The common and significant Grade 1 (G1) and Grade 2 (G2) genitourinary events have also been reported.', 'unitOfMeasure': '% of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue', 'description': 'Technology developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.\n\nStudy is a prospective, multi-center, single arm trial conducted in US, Canada and Europe. All subjects received the same treatment.\n\nTreatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'No. of patients who completed ALL assessments at 12 months post treatment; 1 pt only had PSA test.', 'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MR-Guided Transurethral US Ablation', 'description': 'MR-Guided Transurethral US Ablation of Prostate Tissue\n\nMR-Guided Transurethral US Ablation of Prostate Tissue: The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prescribed prostate tissue.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Multi-racial', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'White/Caucasian', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Data was collected via a questionnaire completed by the patient at the Baseline Visit. Patients were asked to describe themselves by noting a "X" in one box only. Available options included; White/Caucasian; Black/African-American; Latino/Hispanic\' Asian/Pacific Islander; Multi-Racial; Other.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Subjects with erections sufficient for penetration at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Erectile dysfunction was defined as a score of 0-1 for Question 2 of the International Index of Erectile Function (IIEF-15). Patients with erections sufficient for penetration had a score greater than or equal to 2.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline measures were only done for the patients who passed screening and eligibility criteria'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-29', 'studyFirstSubmitDate': '2012-09-13', 'resultsFirstSubmitDate': '2018-08-28', 'studyFirstSubmitQcDate': '2012-09-13', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-24', 'studyFirstPostDateStruct': {'date': '2012-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Treatment Efficacy - Biopsy', 'timeFrame': '12 months from the Treatment Date', 'description': 'Evaluate the effectiveness of the treatment to achieve disease control at 12 months based on biopsy results.'}, {'measure': 'Treatment Efficacy - PSA', 'timeFrame': 'As per the Study Schedule, measured at 1-month, 3-months, 6-months and 12-months from the Treatment Date compared to Baseline', 'description': 'Based on measurements obtained at each study visit, characterize the pattern of PSA response within the first 12 months following treatment in comparison to baseline.'}, {'measure': 'Treatment Efficacy - Quality of Life - Urinary Symptoms', 'timeFrame': 'Baseline and 12-months post Treatment', 'description': 'Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, International Prostate Symptom Score (IPSS), which focuses on urinary symptoms.\n\nTotal Score: 0 - 35 0-7 - mildly symptomatic 8-19 - moderately symptomatic 20-35 - severely symptomatic'}, {'measure': 'Treatment Efficacy - Quality of Life - Erectile Function', 'timeFrame': 'Baseline and 12-months post Treatment', 'description': 'Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, Erectile Function EF domain of the International Index of Erectile Function (IIEF-15), which focuses on erectile symptoms.\n\nMinimum score value - 0 Maximum score value - 30 A higher score corresponds to a better outcome; lower score indicative of erectile dysfunction'}, {'measure': 'Treatment Efficacy - Quality of Life - Bowel Habits', 'timeFrame': 'Baseline and 12-months post Treatment', 'description': 'Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, Bowel Habits domain of the UCLA Prostate Cancer Index Short Form (UCLA-PCl-SF-BH), which focuses on bowel symptoms.\n\nMinimum score value - 0 Maximum score value - 100 A higher score corresponds to better outcome'}], 'primaryOutcomes': [{'measure': 'Safety - Evaluate the Frequency of Treatment Related Adverse Events', 'timeFrame': '12 months from the Treatment Date', 'description': 'All reported adverse events were recorded. The frequency was measured as the number of study participants who experienced a treatment/device related adverse event after receiving treatment delivery with PAD-105, the investigational device.'}, {'measure': 'Safety - Evaluate the Severity of Treatment Related Adverse Events', 'timeFrame': '12 months from the Treatment Date', 'description': 'Severity of treatment/device related adverse events were evaluated in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard (version 4), published by the National Cancer Institute (NCI).\n\nThere was no intraoperative complication, no rectal injury or fistula and no severe urinary incontinence. No Grade 4 (G4) or higher adverse events and only one attributable Grade 3 (G3) event; reported below. The common and significant Grade 1 (G1) and Grade 2 (G2) genitourinary events have also been reported.'}], 'secondaryOutcomes': [{'measure': 'Feasibility - Evaluate the Effectiveness of the Investigational System to Thermally Coagulate Prostate Tissue Conforming to the Target Volume With a High Degree of Accuracy and Precision', 'timeFrame': 'On Treatment Date', 'description': 'Conformal thermal coagulation of prostate tissue will be determined quantitatively using measures of targeting accuracy which compare the spatial difference between the target volume and target temperature isotherm determined from MR thermometry images acquired during treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'High intensity transurethral ultrasound ablation', 'MRI-guided', 'Minimally invasive', 'Real-time temperature feedback control'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '26777228', 'type': 'DERIVED', 'citation': 'Chin JL, Billia M, Relle J, Roethke MC, Popeneciu IV, Kuru TH, Hatiboglu G, Mueller-Wolf MB, Motsch J, Romagnoli C, Kassam Z, Harle CC, Hafron J, Nandalur KR, Chronik BA, Burtnyk M, Schlemmer HP, Pahernik S. Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue in Patients with Localized Prostate Cancer: A Prospective Phase 1 Clinical Trial. Eur Urol. 2016 Sep;70(3):447-55. doi: 10.1016/j.eururo.2015.12.029. Epub 2016 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate that the magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system is safe and feasible to ablate prostate tissue in men with localized prostate cancer.', 'detailedDescription': 'Profound Medical Inc. has developed a novel technology called the MRI-guided transurethral ultrasound therapy system. The technology is developed for patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue.\n\nThe treatment is conducted completely within an MRI suite, which enables real-time temperature images of the heated region to be acquired as the ultrasonic treatment is delivered. Using MRI thermometry during treatment, dynamic temperature feedback control over the intensity of the ultrasound beams and rotation of the Ultrasound Applicator can shape the pattern of thermal coagulation accurately and precisely in the prostate gland, thereby reducing the risk of possible damage to important surrounding anatomy such as the rectum, urinary sphincters, neurovascular bundles and pelvic bone. This coagulation method, therefore, has the potential to have lower complication rates than conventional therapies.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male, age ≥65\n* Patient with low-risk, early-stage organ-confined prostate cancer (Stage T1c or T2a, N0, M0).\n* Gleason score 6 (3+3)\n* Prostate-specific antigen (PSA) ≤ 10 ng/ml\n* Eligible for MR imaging (DOC-10252)\n* Meets the following criteria on pre-treatment transrectal ultrasound imaging:\n\n 1. No cysts or calcifications \\> 1.0 cm in size\n 2. No evidence of extraprostatic extension or seminal vesicle invasion\n 3. Overall prostate size less than 5 cm in sagittal length and less than 7 cm in diameter\n* Biopsy confirmed adenocarcinoma of the prostate, performed at least 6 weeks prior to and no more than 6 months prior to the scheduled treatment.\n* Eligible for General Anesthesia, as defined in American Society of Anesthesiologists (ASA)\n* Normal rectal anatomy and rectal mucosa on digital rectal examination\n\nExclusion Criteria:\n\n* Bleeding disorder\n* Abnormal coagulation and current anticoagulant therapy.\n* Acute or chronic Urinary Tract Infection\n* Interest in future fertility\n* History of allergy relevant medication or other\n* History of any other malignancy other than skin cancer\n* Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome\n* Prior treatment of the prostate gland\n* Prior treatment with 5 alpha reductase inhibitor allowed (not as prostate cancer treatment or prevention) as long as drug has been stopped for minimum 3 months\n* History of any major rectal or pelvic surgery\n* History of ulcerative colitis or other chronic inflammatory conditions affecting rectum\n* History of documented clinical prostatitis requiring therapy within previous 6 months\n* History of urethral and bladder outlet disorders, including urethral stricture disease, urethral diverticulae, bladder neck contracture, urethral fistulae which had required prior urethrotomy, urethral stenting, urethroplasty or chronic indwelling urethral catheter\n* Patients with artificial urinary sphincter or any penile implant (metallic or non-metallic)\n* Neurologic bladder disorders\n* Untreated bladder stones\n* History of acute urinary retention\n* Confirmed or suspected bladder cancer\n* Urinary sphincter abnormalities\n* Active untreated gross hematuria for any cause\n* Post Void Residual (PVR) bladder volume \\> 250 mL\n* Obstructing median lobe enlarged out of proportion to the rest of the prostate and protruding significantly into the bladder\n\nAdditional exclusion criteria on file....'}, 'identificationModule': {'nctId': 'NCT01686958', 'briefTitle': 'Safety Study of MRI-guided Transurethral Ultrasound Ablation of Prostate Tissue to Treat Localized Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Profound Medical Inc.'}, 'officialTitle': 'Phase 1 Study: A Prospective, Multi-center, Single Arm Study - Evaluation of the Safety and Feasibility of MRI-guided Transurethral Ultrasound Therapy for the Ablation of Prostate Tissue in Patients With Localized Prostate Cancer', 'orgStudyIdInfo': {'id': 'DOC-10246'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MR-Guided Transurethral US Ablation', 'description': 'MR-Guided Transurethral US Ablation of Prostate Tissue', 'interventionNames': ['Device: MR-Guided Transurethral US Ablation of Prostate Tissue']}], 'interventions': [{'name': 'MR-Guided Transurethral US Ablation of Prostate Tissue', 'type': 'DEVICE', 'otherNames': ['Prostate Ablation Device: PAD-105'], 'description': 'The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue.', 'armGroupLabels': ['MR-Guided Transurethral US Ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Science Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'German Cancer Research Center (DKFZ)', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Joseph Chin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London Health Science Center'}, {'name': 'James Relle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corewell Health East'}, {'name': 'Ryan Berglund, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}, {'name': 'Heinz P Schlemmer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'German Cancer Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Profound Medical Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}