Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 2:40 AM
Study NCT ID:
NCT04273594
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-28
First Post:
2020-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FemBloc® Permanent Contraception - Confirmation Feasibility Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2020-02-14', 'studyFirstSubmitQcDate': '2020-02-14', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reliance Rate', 'timeFrame': 'within 1 year', 'description': 'Number of subjects told to rely divided by number of qualified subjects'}, {'measure': 'Concordance', 'timeFrame': 'within 1 year', 'description': 'Concordance between FemBloc confirmation with FemChec and Fluoro HSG confirmation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['permanent contraception', 'birth control', 'pregnancy prevention'], 'conditions': ['Contraception']}, 'descriptionModule': {'briefSummary': 'The trial objectives include evaluating the adequacy of proposed mitigations for the previous pivotal trial of the FemBloc Permanent Contraceptive System and validating the confirmation procedure by comparing FemChec (ultrasound) to fluoroscopic hysterosalpingogram (fluoro HSG) for post-occlusion in the same patient.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female, 21 - 45 years of age desiring permanent birth control\n* Sexually active with male partner\n* Regular menstrual cycle for last 3 months or on hormonal contraceptives\n\nExclusion Criteria:\n\n* Uncertainty about the desire to end fertility\n* Known or suspected pregnancy\n* Prior tubal surgery, including sterilization attempt\n* Prior endometrial ablation\n* Presence, suspicion, or previous history of gynecologic malignancy\n* Abnormal uterine bleeding requiring evaluation or treatment\n* Scheduled to undergo concomitant intrauterine procedures at the time of procedure(s)\n* Allergy to shellfish, betadine or iodinated contrast'}, 'identificationModule': {'nctId': 'NCT04273594', 'acronym': 'BLOC', 'briefTitle': 'FemBloc® Permanent Contraception - Confirmation Feasibility Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Femasys Inc.'}, 'officialTitle': 'BLOC: Prospective, Multi-Center, Study of Subjects Undergoing FemBloc Permanent Contraception With Two Confirmation Procedures (FemBloc With FemChec and Fluoro HSG)', 'orgStudyIdInfo': {'id': 'CP-100-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FemBloc', 'description': 'Investigational device and procedure', 'interventionNames': ['Device: FemBloc']}], 'interventions': [{'name': 'FemBloc', 'type': 'DEVICE', 'description': 'Treatment with FemBloc for women who desire permanent birth control (female sterilization)', 'armGroupLabels': ['FemBloc']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'New Horizons Clinical Trials', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Precision Trials AZ, LLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '31909', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Midtown OB GYN North', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '46825', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': "Women's Health Advantage", 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '48604', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': 'Saginaw Valley Medical Research Group', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals - Cleveland Medical Center', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Femasys Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}