NCT03067272

Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Femasys Inc. · Industry
• Sex: Female
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Prospective, multi-center, pilot study evaluating the safety of the FemBloc® Permanent Contraceptive System for female sterilization in preventing pregnancy.

Detailed description

Prospective, multi-center, pilot study of subjects undergoing the FemBloc Permanent Contraceptive System procedure conducted at 5 sites in the U.S. following 49 subjects total. The objective of the trial is to evaluate the safety of the FemBloc Permanent Contraceptive System for female sterilization in preventing pregnancy through the 3-month confirmation test visit. Femasys also intends to continue follow-up of pilot subjects for safety a total duration of approximately 68 months after the FemBloc treatment procedure.

Conditions

• Contraception

Interventions

Type	Name	Description
DEVICE	FemBloc® Permanent Contraceptive System	The FemBloc Permanent Contraceptive System consists of treatment with a Delivery System and Biopolymer, and a confirmation test with the FemChec® Tubal Occlusion Confirmation device as part of a sonographic hysterosalpingogram (Sono HSG).

Timeline

• Start date: 2017-03-15
• Primary completion: 2018-02-27
• Completion: 2023-03-14
• First posted: 2017-03-01
• Last updated: 2023-05-09

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study