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FemBloc® Contraception Pivotal Trial (BLOC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03433911
Recruitment Status : Active, not recruiting
First Posted : February 15, 2018
Last Update Posted : March 16, 2020
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

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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 : February 2, 2018
Actual Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 2025

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



Information from the National Library of Medicine

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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


Locations
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United States, Arizona
Visions Clinical Research - Tucson
Tucson, Arizona, United States, 85712
United States, California
Stanford University
Stanford, California, United States, 94305
United States, Connecticut
The Stamford Hospital
Stamford, Connecticut, United States, 06904
United States, Florida
Altus Research Inc.
Lake Worth, Florida, United States, 33461
Virtus Research Consultants, LLC
Wellington, Florida, United States, 33470
United States, Idaho
Rosemark Womencare Specialists
Idaho Falls, Idaho, United States, 83404
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
Women's Health Advantage
Fort Wayne, Indiana, United States, 46825
United States, New Jersey
Rutgers, The State University of New Jersey
Newark, New Jersey, United States, 07103
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Wake Research Associates, LLC
Raleigh, North Carolina, United States, 27612
United States, Ohio
University Hospitals Cleveland Medical Center
Beachwood, Ohio, United States, 44122
Amy Brenner MD & Associates
Mason, Ohio, United States, 45069
United States, Tennessee
Chattanooga Medical Research LLC
Chattanooga, Tennessee, United States, 37404
United States, Texas
The Woman's Hospital of Texas Clinical Research Center
Houston, Texas, United States, 77054
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Femasys Inc.
Investigators
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Study Director: Sponsor Medical Affairs & Clinical Development

Additional Information:
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Responsible Party: Femasys Inc.
ClinicalTrials.gov Identifier: NCT03433911    
Other Study ID Numbers: CP-100-007
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020

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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
Keywords provided by Femasys Inc.:
Permanent contraception
Birth control