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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03433911
Other study ID # CP-100-007
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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