NCT03433911

FemBloc® Permanent Contraception - Early Pivotal Trial

BLOC: Prospective Multi-Center Office Based Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Femasys Inc. · Industry
• Sex: Female
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Prospective, multi-center, international, non-randomized, two-arm study of subjects undergoing either FemBloc or laparoscopic bilateral tubal sterilization (Control). The FemBloc group total study duration will be approximately 65 months. The laparoscopic tubal sterilization (Control) group total study duration will be approximately 62 months.

Conditions

• Contraception

Interventions

Type	Name	Description
DEVICE	FemBloc	Treatment with FemBloc for women who desire permanent birth control (female sterilization)
PROCEDURE	Laparoscopic bilateral tubal sterilization	Laparoscopic bilateral tubal sterilization for women who desire permanent birth control (female sterilization)

Timeline

• Start date: 2018-02-02
• Primary completion: 2020-01-31
• Completion: 2025-02-10
• First posted: 2018-02-15
• Last updated: 2026-02-27

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study