Status:
ACTIVE_NOT_RECRUITING
FemBloc® Permanent Contraception - Confirmation Feasibility Trial
Lead Sponsor:
Femasys Inc.
Conditions:
Contraception
Eligibility:
FEMALE
21-45 years
Phase:
NA
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 c...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04273594
Start Date
February 27 2020
End Date
April 1 2027
Last Update
January 28 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
New Horizons Clinical Trials
Chandler, Arizona, United States, 85224
2
Precision Trials AZ, LLC
Phoenix, Arizona, United States, 85032
3
Midtown OB GYN North
Columbus, Georgia, United States, 31909
4
Women's Health Advantage
Fort Wayne, Indiana, United States, 46825