Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-20 @ 10:29 AM
Study NCT ID:
NCT00663533
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2008-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VAS-2 Vasectomy With the Vax-X
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-02', 'studyFirstSubmitDate': '2008-04-18', 'studyFirstSubmitQcDate': '2008-04-21', 'lastUpdatePostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'absence of sperm in ejaculated semen 6 months after vasectomy', 'timeFrame': '6-months'}], 'secondaryOutcomes': [{'measure': 'any side effects as well as degree of occlusion of the resected segment of vas deferens', 'timeFrame': '6-months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vasectomy', 'Contraception'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '20154700', 'type': 'DERIVED', 'citation': 'Amory JK, Jessen JW, Muller C, Berger RE. Vasectomy by epithelial curettage without suture or cautery: a pilot study in humans. Asian J Androl. 2010 May;12(3):315-21. doi: 10.1038/aja.2009.94. Epub 2010 Feb 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to study an experimental vasectomy device called the Vas-X. This is an experimental study of this new approach to vasectomy.', 'detailedDescription': 'The Vas-X works by stripping the lining of the vas deferens, the tube that sperm pass through during ejaculation. It is used in a way very similar to routine vasectomy, however, in a routine vasectomy, the vas is burned with an electrical device. With the Vas-X, there is no burning. The investigators are testing the Vas-X to determine whether it will offer a better way of performing a vasectomy.\n\nThe investigators will conduct this study at the University of Washington Medical Center, Seattle.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male with normal physical findings\n* normal testicular volume (15-30mL)\n* detectable sperm in ejaculates\n\nExclusion Criteria:\n\n* Men with past history of\n\n * hypertension\n * significant cardiovascular\n * thromboembolic disorders\n * renal (including undiagnosed urinary tract bleeding)\n * hepatic, prostatic and testicular disease\n * prior vasectomy or scrotal surgery\n * infertility\n* Men with a past history of drug abuse will also be excluded.'}, 'identificationModule': {'nctId': 'NCT00663533', 'acronym': 'VAS-2', 'briefTitle': 'VAS-2 Vasectomy With the Vax-X', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Vasectomy With the Vas-X, a Simple, Minimally Invasive Device for Male Sterilization: A Pilot Study', 'orgStudyIdInfo': {'id': '32431-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Device study only.', 'interventionNames': ['Device: Vas-X']}], 'interventions': [{'name': 'Vas-X', 'type': 'DEVICE', 'description': 'mechanical vasectomy device', 'armGroupLabels': ['Device study only.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'John Amory', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'John Amory', 'investigatorAffiliation': 'University of Washington'}}}}