NCT05977751NARecruitingAccepts Healthy Volunteers
Prospective Multi-Center Trial for FemBloc Permanent Birth Control
Femasys Inc.
Start Date
10/31/2023
Completion Date
6/1/2031
Summary
Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.
Detailed Description
Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.
Eligibility Criteria
Age Range: 21 years to 50 years
Inclusion Criteria:
* Female, 21 - 50 years of age desiring permanent birth control.
* Sexually active with male partner.
* Regular menstrual cycle for last 3 months or on hormonal contraceptives.
Exclusion Criteria:
* Uncertainty about the desire to end fertility.
* Known or suspected pregnancy.
* Prior tubal surgery, including sterilization attempt.
* Presence, suspicion, or previous history of gynecologic malignancy.
* Scheduled to undergo concomitant intrauterine procedures (i.e. endometrial ablation) at the time of either FemBloc Treatment or prior to final confirmation test.
* Abnormal uterine bleeding requiring evaluation or treatment.
Interventions
DEVICE
FemBloc
Conditions
Contraception
Locations
New Horizons Clinical Trials
Chandler, Arizona 85224
United States
Stanford University
Palo Alto, California 94304
United States
University of California Davis
Sacramento, California 95817
United States
Midtown OB GYN North
Columbus, Georgia 31909
United States
Rosemark WomenCare Specialists
Idaho Falls, Idaho 83404
United States
Maimonides Medical Center
Brooklyn, New York 11219-2919
United States
Seven Hills Women's Health Centers
Cincinnati, Ohio 45242
United States
University of Utah
Salt Lake City, Utah 84108
United States