FemBloc® Permanent Contraception - Confirmation Feasibility Trial
BLOC
BLOC: Prospective, Multi-Center, Study of Subjects Undergoing FemBloc Permanent Contraception With Two Confirmation Procedures (FemBloc With FemChec and Fluoro HSG)
1 other identifier
interventional
45
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2020
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2020
CompletedFirst Posted
Study publicly available on registry
February 18, 2020
CompletedStudy Start
First participant enrolled
February 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
ExpectedJanuary 28, 2025
January 1, 2025
2.6 years
February 14, 2020
January 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Reliance Rate
Number of subjects told to rely divided by number of qualified subjects
within 1 year
Concordance
Concordance between FemBloc confirmation with FemChec and Fluoro HSG confirmation
within 1 year
Study Arms (1)
FemBloc
EXPERIMENTALInvestigational device and procedure
Interventions
Treatment with FemBloc for women who desire permanent birth control (female sterilization)
Eligibility Criteria
You may qualify if:
- Female, 21 - 45 years of age desiring permanent birth control
- Sexually active with male partner
- Regular menstrual cycle for last 3 months or on hormonal contraceptives
You may not qualify if:
- Uncertainty about the desire to end fertility
- Known or suspected pregnancy
- Prior tubal surgery, including sterilization attempt
- Prior endometrial ablation
- Presence, suspicion, or previous history of gynecologic malignancy
- Abnormal uterine bleeding requiring evaluation or treatment
- Scheduled to undergo concomitant intrauterine procedures at the time of procedure(s)
- Allergy to shellfish, betadine or iodinated contrast
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Femasys Inc.lead
Study Sites (6)
New Horizons Clinical Trials
Chandler, Arizona, 85224, United States
Precision Trials AZ, LLC
Phoenix, Arizona, 85032, United States
Midtown OB GYN North
Columbus, Georgia, 31909, United States
Women's Health Advantage
Fort Wayne, Indiana, 46825, United States
Saginaw Valley Medical Research Group
Saginaw, Michigan, 48604, United States
University Hospitals - Cleveland Medical Center
Beachwood, Ohio, 44122, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2020
First Posted
February 18, 2020
Study Start
February 27, 2020
Primary Completion
September 30, 2022
Study Completion (Estimated)
April 1, 2027
Last Updated
January 28, 2025
Record last verified: 2025-01