FemBloc® Permanent Contraception - Early Pivotal Trial

Not Applicable

Active, not recruiting

• Conditions: Contraception
• Interventions: Device: FemBloc; Procedure: Laparoscopic bilateral tubal sterilization

• Registration Number: NCT03433911
• Lead Sponsor: Femasys Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-01
• Study Start: 2018-02-02
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-15
• Primary Completion: 2020-01-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-27
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

• Female, 21 - 45 years of age desiring permanent birth control

• Sexually active with male partner

• For FemBloc Arm:

  • Regular menstrual cycle for last 3 months or on hormonal contraceptives

• For Control Arm:

  • Undergoing planned laparoscopic bilateral tubal sterilization

Exclusion Criteria

• Uncertainty about the desire to end fertility
• Known or suspected pregnancy
• Prior tubal surgery, including sterilization attempt
• Prior endometrial ablation
• Presence, suspicion, or previous history of gynecologic malignancy
• Abnormal uterine bleeding requiring evaluation or treatment
• Scheduled to undergo concomitant intrauterine procedures at the time of procedure(s)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FemBloc	FemBloc	Investigational device and procedure
Control	Laparoscopic bilateral tubal sterilization	Laparoscopic bilateral tubal sterilization

Primary Outcome Measures

Name	Time	Method
Incidence of short-term and long-term adverse events in each arm	1-5 years	Safety: Incidence of short-term and long-term adverse events in each arm

Trial Locations

Locations (12)

Amy Brenner MD & Associates; 🇺🇸 Mason, Ohio, United States

Stanford University; 🇺🇸 Stanford, California, United States

Rosemark Womencare Specialists; 🇺🇸 Idaho Falls, Idaho, United States

Chattanooga Medical Research LLC; 🇺🇸 Chattanooga, Tennessee, United States

New Horizons Clinical Trials; 🇺🇸 Chandler, Arizona, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Rutgers, The State University of New Jersey; 🇺🇸 Newark, New Jersey, United States

Women's Health Advantage; 🇺🇸 Fort Wayne, Indiana, United States

Wake Research Associates, LLC; 🇺🇸 Raleigh, North Carolina, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Beachwood, Ohio, United States

Altus Research Inc.; 🇺🇸 Lake Worth, Florida, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States