FemBloc® Permanent Contraception - Early Pivotal Trial (BLOC)

February 15, 2023 updated by: Femasys Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • New Horizons Clinical Trials
    • California
      • Stanford, California, United States, 94305
        • Stanford University
    • Florida
      • Lake Worth, Florida, United States, 33461
        • Altus Research Inc.
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rosemark WomenCare Specialists
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Women's Health Advantage
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Rutgers, The State University of New Jersey
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • University Hospitals Cleveland Medical Center
      • Mason, Ohio, United States, 45069
        • Amy Brenner MD & Associates
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Medical Research LLC
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FemBloc
Investigational device and procedure
Device: FemBloc
Treatment with FemBloc for women who desire permanent birth control (female sterilization)
Active Comparator: Control
Laparoscopic bilateral tubal sterilization
Procedure: Laparoscopic bilateral tubal sterilization
Laparoscopic bilateral tubal sterilization for women who desire permanent birth control (female sterilization)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of short-term and long-term adverse events in each arm
Time Frame: 1-5 years
Safety: Incidence of short-term and long-term adverse events in each arm
1-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Femasys Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2018

Primary Completion (Actual)

January 31, 2020

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

February 1, 2018

First Submitted That Met QC Criteria

February 8, 2018

First Posted (Actual)

February 15, 2018

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CP-100-007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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