FemBloc® Permanent Contraception - Early Pivotal Trial

Contraception Clinical Trial

— BLOC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03433911
• Other study ID #: CP-100-007
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2, 2018
• Est. completion date: January 2025

Study information

• Verified date: February 2023
• Source: Femasys Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: January 2025
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Contraception

Intervention

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)

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Beachwood	Ohio
United States	New Horizons Clinical Trials	Chandler	Arizona
United States	Chattanooga Medical Research LLC	Chattanooga	Tennessee
United States	Women's Health Advantage	Fort Wayne	Indiana
United States	Rosemark Womencare Specialists	Idaho Falls	Idaho
United States	Altus Research Inc.	Lake Worth	Florida
United States	Amy Brenner MD & Associates	Mason	Ohio
United States	Columbia University Medical Center	New York	New York
United States	Rutgers, The State University of New Jersey	Newark	New Jersey
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	University of Utah	Salt Lake City	Utah
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Femasys Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of short-term and long-term adverse events in each arm	Safety: Incidence of short-term and long-term adverse events in each arm	1-5 years

External Links

•   FemBloc Study Website