Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-03 @ 3:19 PM
Study NCT ID:
NCT01999660
Status:
TERMINATED
Last Update Posted:
2021-07-27
First Post:
2013-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-marketing Surveillance Regarding Efficacy and Safety of SpaceOAR™
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'PI did leave hospital (retired)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-21', 'studyFirstSubmitDate': '2013-11-26', 'studyFirstSubmitQcDate': '2013-11-26', 'lastUpdatePostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'feasibility of the implantation procedure', 'timeFrame': '1 day', 'description': 'feasibility of the implantation procedure will be documented by subjective description given by the investigators. this includes safety aspects.'}], 'primaryOutcomes': [{'measure': 'the rectal complication rate (late toxicity)', 'timeFrame': '6 months and yearly for 5 years thereafter', 'description': 'the rectal complication rate following the common toxicity criteria (CTC) v. 2.0'}], 'secondaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': '6 months and for 5 years yearly thereafter', 'description': 'The validated Expanded Prostate Cancer Index Composite (EPIC) questionnaire in combination with the validated Short Form Health Survey (SF-12) will be used to document the influence on the quality of life (QoL).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostatic Neoplasms', 'Radiotherapy', 'rectal toxicity'], 'conditions': ['Prostate Cancer Patients Treated by Radiotherapy']}, 'descriptionModule': {'briefSummary': 'A treatment with SpaceOAR™ hydrogel does reduce late toxicity Grad 2 and Grad 3 of radiation therapy in prostate cancer patients', 'detailedDescription': 'The degradable SpaceOAR™ hydrogel establishes for the time of radiotherapy a distance between the prostate and the rectum'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'prostate cancer patients treated by radiotherapy and prophetically by SpaceOAR™', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is suffering from pathologically confirmed T1-T2, N0, M0 prostate adenocarcinoma.\n* Patient is intended to receive radiation therapy (3D-computerized radiotherapy, intensity-modulated radiotherapy, and/or brachytherapy) and this will be the first prostate or pelvic radiation therapy.\n* Patient is intended to receive SpaceOAR™ Gel therapy.\n* The patient is official patient of the clinical investigator in the study centre.\n* Patient agrees to fully participate in the clinical trial and give informed consent in writing.\n\nExclusion Criteria:\n\n* Anatomic abnormality, physical or pathological condition precluding the implantation.\n* Failure in the wall of the perineum room (with the risk that the hydrogel escapes).\n* History of prostate surgery or local prostate cancer therapy.\n* Rectal injury before implantation of SpaceOAR™ Gel or history of or active inflammatory rectal disease such as Crohn's disease or ulcerative colitis.\n* History of or current perirectal or anal disease or surgery such as prolapsed or bleeding haemorrhoids or fistula.\n* Compromised immune system (e.g., HIV/acquired immunodeficiency syndrome, auto¬immune disease or immunosuppressive therapy).\n* Platelet count, partial thromboplastin time, or white blood cell count out of normal laboratory range.\n* Contraindication for safe MRI and CT scans.\n* Patient is not able to fully participate in this study including the follow-up (e.g. for mental or geographical reasons, or patient is intravenous drug user or has strong potential for non-compliance to medical regimes).\n* Patient is mentally unable to understand the nature, aims, or possible consequences of the clinical investigation.\n* Patient has restricted legal capacity.\n* Patient did participate in another clinical investigation during the last 3 months.\n* Patient has revoked the consent."}, 'identificationModule': {'nctId': 'NCT01999660', 'briefTitle': 'Post-marketing Surveillance Regarding Efficacy and Safety of SpaceOAR™', 'organization': {'class': 'INDUSTRY', 'fullName': 'CS Diagnostics GmbH'}, 'officialTitle': 'Prospective National Post-marketing Surveillance for the Investigation of the Efficacy and Safety of SpaceOAR™ to Maintain Space Between the Rectum and Prostate During Radiation Therapy', 'orgStudyIdInfo': {'id': 'Space-CS-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SpaceOAR™', 'description': 'prostate cancer patient prophetically treated by SpaceOAR™', 'interventionNames': ['Device: SpaceOAR™ implantation']}], 'interventions': [{'name': 'SpaceOAR™ implantation', 'type': 'DEVICE', 'armGroupLabels': ['SpaceOAR™']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45879', 'city': 'Gelsenkirchen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen', 'geoPoint': {'lat': 51.50508, 'lon': 7.09654}}], 'overallOfficials': [{'name': 'Razvan Galalae, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CS Diagnostics GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Aix Scientifics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}