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FemBloc® Contraception Pivotal Trial (BLOC)

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ClinicalTrials.gov Identifier: NCT03433911
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Contraception Device: FemBloc Procedure: Laparoscopic bilateral tubal sterilization Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 975 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: BLOC: Prospective Multi-Center Office Based Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Confirmed pregnancy rate for subjects told to rely on FemBloc for birth control [ Time Frame: 1 year from being told to rely ]
    Confirmed pregnancy rate for subjects told to rely on FemBloc for birth control

  2. Reliance rate [ Time Frame: Within 1 year ]
    Number of subjects told to rely divided by number of qualified subjects


Secondary Outcome Measures :
  1. Long-term pregnancy rate for subjects told to rely on FemBloc for birth control [ Time Frame: 2-5 years ]
    Long-term pregnancy rate for subjects told to rely on FemBloc for birth control

  2. 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

  3. Satisfaction/comfort assessed by questionnaire [ Time Frame: 1-5 years ]
    Satisfaction/comfort assessed by subject questionnaire at various timepoints



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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433911


Contacts
Contact: Study Director 770-500-3910 ext 146 Studysupport@femasys.com

Locations
United States, Arizona
Visions Clinical Research - Tucson Recruiting
Tucson, Arizona, United States, 85712
United States, California
Women's Health Clinical Research Unit, UCLA Department of Obstetrics and Gynecology Recruiting
Los Angeles, California, United States, 90095
Wr-McCr, Llc Recruiting
San Diego, California, United States, 92108
Stanford University Recruiting
Stanford, California, United States, 94305
United States, Connecticut
The Stamford Hospital Recruiting
Stamford, Connecticut, United States, 06904
United States, Florida
Altus Research Inc. Recruiting
Lake Worth, Florida, United States, 33461
Virtus Research Consultants, LLC Recruiting
Wellington, Florida, United States, 33470
United States, Georgia
Agile Clinical Research Trials, LLC Recruiting
Atlanta, Georgia, United States, 30342
United States, Idaho
Rosemark Womencare Specialists Recruiting
Idaho Falls, Idaho, United States, 83404
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, Nevada
Women's Center of Nevada Recruiting
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Rutgers, The State University of New Jersey Recruiting
Newark, New Jersey, United States, 07103
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
United States, North Carolina
Wake Research Associates, LLC Recruiting
Raleigh, North Carolina, United States, 27612
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Beachwood, Ohio, United States, 44122
Amy Brenner MD & Associates Recruiting
Mason, Ohio, United States, 45069
United States, Tennessee
Chattanooga Medical Research LLC Recruiting
Chattanooga, Tennessee, United States, 37404
United States, Texas
Baylor, Scott and White Research Institute Recruiting
Fort Worth, Texas, United States, 76104
The Woman's Hospital of Texas Clinical Research Center Recruiting
Houston, Texas, United States, 77054
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Femasys Inc.
Investigators
Study Director: Sponsor Medical Affairs & Clinical Development

Additional Information:
Responsible Party: Femasys Inc.
ClinicalTrials.gov Identifier: NCT03433911     History of Changes
Other Study ID Numbers: CP-100-007
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Femasys Inc.:
Permanent contraception
Birth control