Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT05977751
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2023-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Multi-Center Trial for FemBloc Permanent Birth Control
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': 'ESTIMATED', 'count': 573}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2031-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2023-07-27', 'studyFirstSubmitQcDate': '2023-08-03', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy Rate', 'timeFrame': 'one (1) year', 'description': 'Number of subjects who were told to rely on FemBloc for birth control and became pregnant through one (1) year.'}], 'secondaryOutcomes': [{'measure': 'Reliance Rate', 'timeFrame': 'ninety (90) days post treatment', 'description': 'Number of subjects who were told to rely on FemBloc.'}, {'measure': 'Long term Pregnancy Rate', 'timeFrame': 'Five (5) years', 'description': 'Number of subjects who were told to rely on FemBloc for birth control that became pregnant after one (1) year through 2-, 3-, 4-, and 5-years.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Permanent Birth Control', 'Permanent Contraception', 'Permanent Sterilization'], 'conditions': ['Contraception']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.fembloc.com/', 'label': 'FemBloc Clinical Study Website'}]}, 'descriptionModule': {'briefSummary': 'Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.', 'detailedDescription': 'Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female, 21 - 50 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* Presence, suspicion, or previous history of gynecologic malignancy.\n* Scheduled to undergo concomitant intrauterine procedures (i.e. endometrial ablation) at the time of either FemBloc Treatment or prior to final confirmation test.\n* Abnormal uterine bleeding requiring evaluation or treatment.'}, 'identificationModule': {'nctId': 'NCT05977751', 'acronym': 'FINALE', 'briefTitle': 'Prospective Multi-Center Trial for FemBloc Permanent Birth Control', 'organization': {'class': 'INDUSTRY', 'fullName': 'Femasys Inc.'}, 'officialTitle': 'FINALE: Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control', 'orgStudyIdInfo': {'id': 'CP-100-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FemBloc', 'description': 'Investigational device and procedure', 'interventionNames': ['Device: FemBloc']}], 'interventions': [{'name': 'FemBloc', 'type': 'DEVICE', 'description': 'Treatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes.', 'armGroupLabels': ['FemBloc']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Research Coordinator', 'role': 'CONTACT', 'phone': '650-497-5175'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Research Coordinator', 'role': 'CONTACT', 'phone': '916-734-6846'}], 'facility': 'University of California Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '31909', 'city': 'Columbus', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Research Coordinator', 'role': 'CONTACT', 'phone': '706-320-2547'}], 'facility': 'Midtown OB GYN North', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '11219-2919', 'city': 'Brooklyn', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Research Coordinator', 'role': 'CONTACT', 'phone': '718-283-7962'}], 'facility': 'Maimonides Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Research Coordinator', 'role': 'CONTACT', 'phone': '513-290-3221'}], 'facility': "Seven Hills Women's Health Centers", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Research Coordinator', 'role': 'CONTACT', 'phone': '801-231-2774'}], 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'StudySupport@Femasys.com', 'phone': '770-500-3910 Ext. 146'}], 'overallOfficials': [{'name': 'Study Sponsor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Affairs and Clinical Development'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Femasys Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}