MedTrace Logo

FemBloc® Permanent Contraception - Early Pivotal Trial

NCT03433911 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-02-27

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Femasys Inc.

    lead INDUSTRY

Principal Investigators

  • Sponsor · Medical Affairs & Clinical Development

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-02
Primary Completion
2020-01-31
Completion
2025-02-10
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03433911 on ClinicalTrials.gov