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FemBloc® Permanent Contraception - Confirmation Feasibility Trial
Sponsor: Femasys Inc.
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.
Official title: BLOC: Prospective, Multi-Center, Study of Subjects Undergoing FemBloc Permanent Contraception With Two Confirmation Procedures (FemBloc With FemChec and Fluoro HSG)
Key Details
Gender
FEMALE
Age Range
21 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2020-02-27
Completion Date
2027-04
Last Updated
2025-01-28
Healthy Volunteers
Yes
Conditions
Interventions
FemBloc
Treatment with FemBloc for women who desire permanent birth control (female sterilization)
Locations (6)
New Horizons Clinical Trials
Chandler, Arizona, United States
Precision Trials AZ, LLC
Phoenix, Arizona, United States
Midtown OB GYN North
Columbus, Georgia, United States
Women's Health Advantage
Fort Wayne, Indiana, United States
Saginaw Valley Medical Research Group
Saginaw, Michigan, United States
University Hospitals - Cleveland Medical Center
Beachwood, Ohio, United States