Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-31 @ 6:31 PM
Study NCT ID:
NCT00335361
Status:
UNKNOWN
Last Update Posted:
2007-04-06
First Post:
2006-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implantable Device for Male Reproductive Sterilization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2009-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-04-05', 'studyFirstSubmitDate': '2006-06-07', 'studyFirstSubmitQcDate': '2006-06-07', 'lastUpdatePostDateStruct': {'date': '2007-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful IVD implantation with vas deferens occlusion at 6 and 24 months post-implant.'}, {'measure': 'The IVD consists of a tubular silicone plug that is inserted into the lumen of the vas deferens to block the flow of semen.'}, {'measure': 'IVD implantation does not require the need to sever or permanently damage the vas deferens like the Ligation/Excision, Clip devices, Cautery'}, {'measure': 'techniques or Fascial Interposition require. One major advantage of the IVD is that it'}, {'measure': 'does not require excision and removal of a portion of the vas. Implantation of the IVD'}, {'measure': 'allows the vas deferens to remain intact and not be permanently damaged.'}]}, 'conditionsModule': {'keywords': ['Male Contraceptive Devices', 'Intra Vas Device (IVD)', 'Male Sterilization', 'Vasectomy', 'Intra Vas Deferens Occlusion', 'Vas Occlusion'], 'conditions': ['Male Sterilization']}, 'descriptionModule': {'briefSummary': 'The study is to evaluate a device for male reproductive sterilization and determine if this device is successful at blocking the sperm.\n\nNinety subjects from two centers in the United Stated will be followed closely for 24 months.\n\nIf you are someone interested in a vasectomy, you may be eligible to participate in this clinical study.', 'detailedDescription': 'This feasibility study is intended to collect pertinent clinical information on the use of the Shepherd Medical Intra Vas Device (IVD) necessary to support the design of a future pivotal study. The IVD is intended to occlude the vas deferens and thus accomplish male reproductive sterilization and to offer an additional method to vasectomy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject desires to undergo a vasectomy.\n2. Freely consents to participate in the Study a\n3. Agrees to provide a semen sample at regularized periods for at least 30 months.\n4. Willing to use a redundant method of contraception until successful occlusion is confirmed.\n5. Agrees to provide follow-up information.\n6. Willing and able to understand and agree to follow all aspects of the procedures and Study requirements.\n7. At least 18 years of age.\n\nExclusion Criteria:\n\n1. Has a condition permanently or temporarily making participation in the Study inadvisable.\n2. Has a condition permanently or temporarily making a vasectomy inadvisable.\n3. Has had a previous successful/unsuccessful vasectomy.\n4. Has had an allergic reaction to silicone and/or ethylene.'}, 'identificationModule': {'nctId': 'NCT00335361', 'briefTitle': 'Implantable Device for Male Reproductive Sterilization', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shepherd Medical Company'}, 'officialTitle': 'The Intra Vas Device (IVD) As A Means of Male Reproductive Sterilization A Single Armed Feasibility Study', 'orgStudyIdInfo': {'id': 'G050215'}, 'secondaryIdInfos': [{'id': 'NIH grant # R44HD046318'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Intra Vas Device (IVD)', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Douglas G. Stein, MD, PA', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '71106', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Regional Urology, LLC', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '56377', 'city': 'Sartell', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Adult and Pediatric Urology', 'geoPoint': {'lat': 45.62163, 'lon': -94.20694}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shepherd Medical Company', 'class': 'INDUSTRY'}}}}