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FemBloc® Permanent Contraception - Confirmation Feasibility 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04273594
Recruitment Status : Recruiting
First Posted : February 18, 2020
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
Femasys Inc.

Brief Summary:
The purpose of this study is to evaluate if changes to the FemBloc Permanent Contraceptive System are effective in increasing reliance (the ability of a woman to be able to depend on FemBloc for contraception once the treatment and confirmation test have been performed), and decreasing pregnancy rate. In addition, the study will compare the FemChec confirmation procedure to that of fluoroscopic HSG, a well-established method of confirmation.

Condition or disease Intervention/treatment Phase
Contraception Device: FemBloc Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: BLOC: Prospective, Multi-Center, Study of Subjects Undergoing FemBloc Permanent Contraception With Two Confirmation Procedures (FemBloc With FemChec and Fluoro HSG)
Actual Study Start Date : February 27, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: FemBloc
Investigational device and procedure
Device: FemBloc
Treatment with FemBloc for women who desire permanent birth control (female sterilization)




Primary Outcome Measures :
  1. Reliance Rate [ Time Frame: within 1 year ]
    Number of subjects told to rely divided by number of qualified subjects

  2. Concordance [ Time Frame: within 1 year ]
    Concordance of Fluoroscopic HSG to FemBloc confirmation with FemChec



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
  • Regular menstrual cycle for last 3 months or on hormonal contraceptives

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)
  • Allergy to shellfish, betadine or iodinated contrast

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): NCT04273594


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

Locations
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United States, Arizona
New Horizon Clinical Trials Recruiting
Chandler, Arizona, United States, 85224
Precision Trials AZ, LLC Recruiting
Phoenix, Arizona, United States, 85032
United States, Indiana
Women's Health Advantage Recruiting
Fort Wayne, Indiana, United States, 46825
United States, Michigan
Saginaw Valley Medical Research Group Recruiting
Saginaw, Michigan, United States, 48604
United States, Ohio
University Hospitals - Cleveland Medical Center Recruiting
Beachwood, Ohio, United States, 44122
Sponsors and Collaborators
Femasys Inc.
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Responsible Party: Femasys Inc.
ClinicalTrials.gov Identifier: NCT04273594    
Other Study ID Numbers: CP-100-008
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 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
pregnancy prevention