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FemBloc® Permanent Contraception - Early 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 : August 26, 2021
Sponsor:
Information provided by (Responsible Party):
Femasys Inc.

Tracking Information
First Submitted Date  ICMJE February 1, 2018
First Posted Date  ICMJE February 15, 2018
Last Update Posted Date August 26, 2021
Actual Study Start Date  ICMJE February 2, 2018
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2021)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2018)
  • 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
  • Reliance rate [ Time Frame: Within 1 year ]
    Number of subjects told to rely divided by number of qualified subjects
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2018)
  • 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
  • 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
  • Satisfaction/comfort assessed by questionnaire [ Time Frame: 1-5 years ]
    Satisfaction/comfort assessed by subject questionnaire at various timepoints
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FemBloc® Permanent Contraception - Early Pivotal Trial
Official Title  ICMJE BLOC: Prospective Multi-Center Office Based Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Contraception
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Experimental: FemBloc
    Investigational device and procedure
    Intervention: Device: FemBloc
  • Active Comparator: Control
    Laparoscopic bilateral tubal sterilization
    Intervention: Procedure: Laparoscopic bilateral tubal sterilization
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 20, 2021)
240
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2018)
975
Estimated Study Completion Date  ICMJE January 2025
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03433911
Other Study ID Numbers  ICMJE CP-100-007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Femasys Inc.
Study Sponsor  ICMJE Femasys Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sponsor Medical Affairs & Clinical Development
PRS Account Femasys Inc.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP