Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05405218
Status:
COMPLETED
Last Update Posted:
2025-06-05
First Post:
2022-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Trial of Ultrasound Guided Carpal Tunnel Release Versus Traditional Open Release (TUTOR)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}, {'id': 'D020423', 'term': 'Median Neuropathy'}], 'ancestors': [{'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'astegner@sonexhealth.com', 'phone': '(888) 518-8780', 'title': 'Amy Stegner, Vice President Clinical Affairs', 'organization': 'Sonex Health, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected out to 1 year.', 'description': 'AE could be reported 3 ways. 1) Documented by the site during the study procedure. 2) Subject reported an AE directly to the investigative site. 3) AE identified by the site during the review of the subject-uploaded wound healing images. If the site identifies a potential AE based on an image review or is notified of a potential AE by the subject, confirmation of the AE will occurred by phone call with the subject or by asking the subject to return for a follow-up clinical evaluation.', 'eventGroups': [{'id': 'EG000', 'title': 'Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device', 'description': 'Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.', 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 1, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Mini Open Carpal Tunnel Release (mOCTR)', 'description': 'Participants who were randomized to and treated with the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 1, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nerve Injury - Digital-Median: Neurapraxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other'}, {'term': 'Wound Dehiscence/ delayed healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other'}], 'seriousEvents': [{'term': 'Nerve Injury - Digital-Median', 'notes': 'Epineurial laceration without axonal disruption on the dorsal aspect of the third common digital nerve, 2 cm distal to its median nerve origin. A nerve wrap was placed and the incision was closed with sutures.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device', 'description': 'Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.'}, {'id': 'OG001', 'title': 'Mini Open Carpal Tunnel Release (mOCTR)', 'description': 'Participants who were randomized to and treated with the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '-1.4'}, {'value': '-1.5', 'groupId': 'OG001', 'lowerLimit': '-1.7', 'upperLimit': '-1.4'}]}]}], 'analyses': [{'pValue': '0.46', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 Month Follow-Up', 'description': 'The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) is a Carpal Tunnel Syndrome specific questionnaire that has been shown to be highly reproducible, internally consistent, valid, and responsive to clinical change in Carpal Tunnel Syndrome (CTS) and subject status post-carpal tunnel release (CTR). The BCTQ consists of 11 symptom severity questions (BCTQ-SSS). Scoring for the BCTQ- SSS ranges from 1 to 5, with higher scores indicating more severe symptoms, and is calculated as the mean of each response. The mean change scores in BCTQ-SSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased symptom severity and positive change scores indicate increased symptom severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) change at 3 months'}, {'type': 'PRIMARY', 'title': 'Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device', 'description': 'Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.'}, {'id': 'OG001', 'title': 'Mini Open Carpal Tunnel Release (mOCTR)', 'description': 'Participants who were randomized to and treated with the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '-0.7'}, {'value': '-0.8', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '-0.7'}]}]}], 'analyses': [{'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.23', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 Month Follow-Up', 'description': 'The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) additionally consists of 8 functional status questions. Scoring for the BCTQ-FSS ranges from 1 to 5, with higher scores indicating more functional limitation, and is calculated as the mean of each response. The mean change scores in BCTQ-FSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased functional limitation and positive change scores indicate increased functional limitation.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) change at 3 months'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participants With Device or Procedure Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device', 'description': 'Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.'}, {'id': 'OG001', 'title': 'Mini Open Carpal Tunnel Release (mOCTR)', 'description': 'Participants who were randomized to and treated with the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 Month Follow-Up', 'description': 'Participants with adverse events (AEs) occurring within 90 days of treatment and that are adjudicated as definitely related or probably related to the device or definitely related or probably related to the procedure will be included in this endpoint. The incidence of device- or procedure-related AEs within 90 days of treatment in each study group will represent an endpoint of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with Procedure and/or Device-Related Adjudicated Adverse Events'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Numeric Pain Scale Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device', 'description': 'Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.'}, {'id': 'OG001', 'title': 'Mini Open Carpal Tunnel Release (mOCTR)', 'description': 'Participants who were randomized to and treated with the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.2', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '-2.8'}, {'value': '-3.8', 'groupId': 'OG001', 'lowerLimit': '-4.4', 'upperLimit': '-3.2'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '1.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 Month Follow-Up', 'description': 'The Numeric Pain Scale measures pain severity. Scoring for the Numeric Pain Scale ranges from 0 (indicating no pain) to 10 (indicating worst pain possible). The mean change scores in the Numeric Pain Scale from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased pain severity and positive change scores indicate increased pain severity.', 'unitOfMeasure': 'Unit', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Numeric Pain Scale change at 3 months'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'EuroQol 5-Dimension 5-Level (EQ-5D-5L) Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device', 'description': 'Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.'}, {'id': 'OG001', 'title': 'Mini Open Carpal Tunnel Release (mOCTR)', 'description': 'Participants who were randomized to and treated with the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '0.14'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '0.07', 'upperLimit': '0.16'}]}]}], 'analyses': [{'pValue': '0.9', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 Month Follow-Up', 'description': 'The EuroQol 5-Dimension 5-Level (EQ-5D-5L) is a generic preference-based questionnaire developed by the EuroQol Group to measure health-related quality of life. The EQ-5D-5L measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking consisting of: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Scoring for the EQ-5D-5L ranges from -0.57 (indicating lowest quality of life) to 1.00 (indicating highest quality of life). The mean change scores in the EQ-5D-5L from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased quality of life and positive change scores indicate increased quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'EuroQol 5-Dimension 5-Level (EQ-5D-5L) change at 3 months'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to Return to Work Among Employed Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device', 'description': 'Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.'}, {'id': 'OG001', 'title': 'Mini Open Carpal Tunnel Release (mOCTR)', 'description': 'Participants who were randomized to and treated with the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '8.5'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '15.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 Month Follow-Up', 'description': 'The time to return to work will be defined as the number of days between treatment and the time the subject reports returning to work in any capacity.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Time to return to work in days among employed subjects'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participants Who Returned to Normal Daily Activities Within 3 Days Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device', 'description': 'Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.'}, {'id': 'OG001', 'title': 'Mini Open Carpal Tunnel Release (mOCTR)', 'description': 'Participants who were randomized to and treated with the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 Month Follow-Up', 'description': 'The time to return to normal daily activities will be defined as the number of days between treatment and the time the subject reports returning to normal daily activities, irrespective of work status.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who returned to normal daily activities within 3 days postoperatively'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device', 'description': 'Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.'}, {'id': 'FG001', 'title': 'Mini Open Carpal Tunnel Release (mOCTR)', 'description': 'Participants who were randomized to and treated with the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Enrollment in the TUTOR study began on August 8, 2022, and 122 subjects were enrolled. Enrollment was completed on February 2, 2023. Per the protocol, a subject was considered enrolled once they had signed the informed consent form, met all inclusion and exclusion criteria, and completed carpal tunnel release (CTR) via their assigned treatment method.', 'preAssignmentDetails': 'No pre-assignments for this study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device', 'description': 'Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.'}, {'id': 'BG001', 'title': 'Mini Open Carpal Tunnel Release (mOCTR)', 'description': 'Participants who were randomized to and treated using the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '14', 'groupId': 'BG000'}, {'value': '57', 'spread': '14', 'groupId': 'BG001'}, {'value': '57', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-18', 'size': 553902, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-14T11:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2022-05-31', 'resultsFirstSubmitDate': '2024-12-08', 'studyFirstSubmitQcDate': '2022-05-31', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-16', 'studyFirstPostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Participants With Device or Procedure Related Adverse Events', 'timeFrame': '3 Month Follow-Up', 'description': 'Participants with adverse events (AEs) occurring within 90 days of treatment and that are adjudicated as definitely related or probably related to the device or definitely related or probably related to the procedure will be included in this endpoint. The incidence of device- or procedure-related AEs within 90 days of treatment in each study group will represent an endpoint of the study.'}, {'measure': 'Numeric Pain Scale Change', 'timeFrame': '3 Month Follow-Up', 'description': 'The Numeric Pain Scale measures pain severity. Scoring for the Numeric Pain Scale ranges from 0 (indicating no pain) to 10 (indicating worst pain possible). The mean change scores in the Numeric Pain Scale from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased pain severity and positive change scores indicate increased pain severity.'}, {'measure': 'EuroQol 5-Dimension 5-Level (EQ-5D-5L) Change', 'timeFrame': '3 Month Follow-Up', 'description': 'The EuroQol 5-Dimension 5-Level (EQ-5D-5L) is a generic preference-based questionnaire developed by the EuroQol Group to measure health-related quality of life. The EQ-5D-5L measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking consisting of: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Scoring for the EQ-5D-5L ranges from -0.57 (indicating lowest quality of life) to 1.00 (indicating highest quality of life). The mean change scores in the EQ-5D-5L from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased quality of life and positive change scores indicate increased quality of life.'}, {'measure': 'Time to Return to Work Among Employed Subjects', 'timeFrame': '3 Month Follow-Up', 'description': 'The time to return to work will be defined as the number of days between treatment and the time the subject reports returning to work in any capacity.'}, {'measure': 'Participants Who Returned to Normal Daily Activities Within 3 Days Postoperatively', 'timeFrame': '3 Month Follow-Up', 'description': 'The time to return to normal daily activities will be defined as the number of days between treatment and the time the subject reports returning to normal daily activities, irrespective of work status.'}], 'primaryOutcomes': [{'measure': 'Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) Change', 'timeFrame': '3 Month Follow-Up', 'description': 'The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) is a Carpal Tunnel Syndrome specific questionnaire that has been shown to be highly reproducible, internally consistent, valid, and responsive to clinical change in Carpal Tunnel Syndrome (CTS) and subject status post-carpal tunnel release (CTR). The BCTQ consists of 11 symptom severity questions (BCTQ-SSS). Scoring for the BCTQ- SSS ranges from 1 to 5, with higher scores indicating more severe symptoms, and is calculated as the mean of each response. The mean change scores in BCTQ-SSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased symptom severity and positive change scores indicate increased symptom severity.'}, {'measure': 'Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) Change', 'timeFrame': '3 Month Follow-Up', 'description': 'The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) additionally consists of 8 functional status questions. Scoring for the BCTQ-FSS ranges from 1 to 5, with higher scores indicating more functional limitation, and is calculated as the mean of each response. The mean change scores in BCTQ-FSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased functional limitation and positive change scores indicate increased functional limitation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Carpal Tunnel Syndrome', 'CTS', 'Carpal Tunnel']}, 'referencesModule': {'references': [{'pmid': '37254502', 'type': 'DERIVED', 'citation': 'Eberlin KR, Amis BP, Berkbigler TP, Dy CJ, Fischer MD, Gluck JL, Kaplan FTD, McDonald TJ, Miller LE, Palmer A, Perry PE, Walker ME, Watt JF. Multicenter randomized trial of carpal tunnel release with ultrasound guidance versus mini-open technique. Expert Rev Med Devices. 2023 Jul;20(7):597-605. doi: 10.1080/17434440.2023.2218548. Epub 2023 May 30.'}, {'pmid': '36254038', 'type': 'DERIVED', 'citation': 'Eberlin KR, Dy CJ, Fischer MD, Gluck JL, Kaplan FTD, McDonald TJ, Miller LE, Palmer A, Walker ME, Watt JF. Trial of ultrasound guided carpal tunnel release versus traditional open release (TUTOR). Medicine (Baltimore). 2022 Oct 14;101(41):e30775. doi: 10.1097/MD.0000000000030775.'}]}, 'descriptionModule': {'briefSummary': 'Study to compare the safety and effectiveness of carpal tunnel release with ultrasound guidance (CTR-US) vs. mini-open carpal tunnel release (mOCTR) in patients with symptomatic carpal tunnel syndrome (CTS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. ≥18 years of age\n2. Clinical diagnosis of unilateral or bilateral idiopathic CTS\n3. CTS-6 score \\>12 in target hand\n4. Absence of carpal tunnel symptoms in the contralateral hand that interfere with normal daily activities or work at the time of consent and are not anticipated to interfere with return to activities or return to work within at least 3 months post-operatively\n5. Median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region of the target hand measured by diagnostic ultrasound\n6. Prior failure of one or more nonsurgical treatment options for the target hand (e.g., physical activity modification, bracing, splinting, corticosteroid injection)\n7. Subject agrees to complete follow-up questionnaires over a 12-month period\n8. Subject has a valid mobile phone number and email address to receive and answer follow-up questionnaires\n\nExclusion Criteria:\n\n1. Prior surgery on the target wrist or hand with the exception of trigger finger that has clinically recovered\n2. History of prior surgical CTR procedure in the target hand\n3. History of prior surgical CTR in the contralateral hand within 3 months of enrollment or with persistent symptoms that interfere with normal daily activities or work at the time of consent\n4. Corticosteroid injection in the target wrist or hand within 6 weeks of study procedure date\n5. Presence of additional process in the target wrist or hand requiring additional intervention beyond carpal tunnel release (e.g. neurolysis, mass removal, tenosynovectomy)\n6. Clinically significant degenerative arthritis of the upper limb (shoulder to hand) on the target side\n7. Clinically significant inflammatory disease (including tenosynovitis) of the upper limb (shoulder to hand) on the target side\n8. Clinically significant trauma or deformity of the upper limb (shoulder to hand) on the target side\n9. Clinically significant vascular disease (including Raynaud's phenomenon) of the upper limb (shoulder to hand) on the target side\n10. Clinically significant neurological disorder (including complex regional pain syndrome) of the upper limb (shoulder to hand) on the target side\n11. Planned surgical or interventional procedure on the contralateral wrist or hand\n12. Systemic inflammatory disease (e.g., rheumatoid arthritis, lupus)\n13. Amyloidosis\n14. Chronic renal insufficiency requiring dialysis\n15. Diabetes not controlled by a stable dose of medication over the past three months\n16. Uncontrolled thyroid disease\n17. Pregnant or planning pregnancy in the next 12 months\n18. Workers compensation subjects\n19. Inability to provide a legally acceptable Informed Consent Form and/or comply with all follow-up requirements\n20. Subject has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations"}, 'identificationModule': {'nctId': 'NCT05405218', 'acronym': 'TUTOR', 'briefTitle': 'Trial of Ultrasound Guided Carpal Tunnel Release Versus Traditional Open Release (TUTOR)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sonex Health, Inc.'}, 'officialTitle': 'Trial of Ultrasound Guided Carpal Tunnel Release Versus Traditional Open Release (TUTOR)', 'orgStudyIdInfo': {'id': '90079-TP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device', 'interventionNames': ['Device: CTR with Ultrasound Guidance using the UltraGuideCTR device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mini Open Carpal Tunnel Release (mOCTR)', 'interventionNames': ['Procedure: mOCTR']}], 'interventions': [{'name': 'CTR with Ultrasound Guidance using the UltraGuideCTR device', 'type': 'DEVICE', 'description': 'Carpal Tunnel Release with Ultrasound Guidance using UltraGuideCTR device', 'armGroupLabels': ['Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device']}, {'name': 'mOCTR', 'type': 'PROCEDURE', 'description': 'Mini Open Carpal Tunnel Release', 'armGroupLabels': ['Mini Open Carpal Tunnel Release (mOCTR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95370', 'city': 'Sonora', 'state': 'California', 'country': 'United States', 'facility': 'Sierra Orthopedic Institute', 'geoPoint': {'lat': 37.98409, 'lon': -120.38214}}, {'zip': '32547', 'city': 'Fort Walton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Orthopedic Associates', 'geoPoint': {'lat': 30.42059, 'lon': -86.61707}}, {'zip': '47715', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Tri-State Orthopaedics', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Hand to Shoulder', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '67205', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas Orthopaedic Center', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55441', 'city': 'Plymouth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Twin Cities Orthopedics', 'geoPoint': {'lat': 45.01052, 'lon': -93.45551}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '63640', 'city': 'Farmington', 'state': 'Missouri', 'country': 'United States', 'facility': 'Midwest Orthopedic Group', 'geoPoint': {'lat': 37.78088, 'lon': -90.42179}}, {'zip': '64064', 'city': "Lee's Summit", 'state': 'Missouri', 'country': 'United States', 'facility': 'Sano Orthopedics', 'geoPoint': {'lat': 38.91084, 'lon': -94.38217}}, {'zip': '63129', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'ATX Orthopedics', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Kyle Eberlin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonex Health, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}