FemBloc® Permanent Contraception - Confirmation Feasibility Trial

Not Applicable

Active, not recruiting

• Conditions: Contraception
• Interventions: Device: FemBloc

• Registration Number: NCT04273594
• Lead Sponsor: Femasys Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-18
• Study Start: 2020-02-27
• Primary Completion: 2022-09-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

• Female, 21 - 45 years of age desiring permanent birth control
• Sexually active with male partner
• Regular menstrual cycle for last 3 months or on hormonal contraceptives

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)
• Allergy to shellfish, betadine or iodinated contrast

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FemBloc	FemBloc	Investigational device and procedure

Primary Outcome Measures

Name	Time	Method
Concordance	within 1 year	Concordance between FemBloc confirmation with FemChec and Fluoro HSG confirmation
Reliance Rate	within 1 year	Number of subjects told to rely divided by number of qualified subjects

Trial Locations

Locations (6)

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

Precision Trials AZ, LLC; 🇺🇸 Phoenix, Arizona, United States

Saginaw Valley Medical Research Group; 🇺🇸 Saginaw, Michigan, United States

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

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

Midtown OB GYN North; 🇺🇸 Columbus, Georgia, United States