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Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception (BLOC)

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ClinicalTrials.gov Identifier: NCT03067272
Recruitment Status : Active, not recruiting
First Posted : March 1, 2017
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Femasys Inc.

Tracking Information
First Submitted Date  ICMJE February 17, 2017
First Posted Date  ICMJE March 1, 2017
Last Update Posted Date October 14, 2020
Actual Study Start Date  ICMJE March 15, 2017
Actual Primary Completion Date February 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2017)
Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc treatment procedure [ Time Frame: 5 months ]
Evaluated up to 3 months after the FemBloc treatment procedure
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: May 7, 2017)
  • Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc Confirmation test [ Time Frame: 5 months ]
    Evaluated at 3 months after the FemBloc treatment procedure
  • Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc Biopolymer [ Time Frame: 5 months ]
    Evaluated up to 3 months after the FemBloc treatment procedure
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
Official Title  ICMJE Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
Brief Summary Prospective, multi-center, pilot study evaluating the safety of the FemBloc® Permanent Contraceptive System for female sterilization in preventing pregnancy.
Detailed Description Prospective, multi-center, pilot study of subjects undergoing the FemBloc Permanent Contraceptive System procedure conducted at 5 sites in the U.S. following 49 subjects total. The objective of the trial is to evaluate the safety of the FemBloc Permanent Contraceptive System for female sterilization in preventing pregnancy through the 3-month confirmation test visit. Femasys also intends to continue follow-up of pilot subjects for safety a total duration of approximately 68 months after the FemBloc treatment procedure.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Contraception
Intervention  ICMJE Device: FemBloc® Permanent Contraceptive System
The FemBloc Permanent Contraceptive System consists of treatment with a Delivery System and Biopolymer, and a confirmation test with the FemChec® Tubal Occlusion Confirmation device as part of a sonographic hysterosalpingogram (Sono HSG).
Study Arms  ICMJE Experimental: FemBloc® Permanent Contraceptive System
Treatment of women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes.
Intervention: Device: FemBloc® Permanent Contraceptive System
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: January 17, 2018)
49
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE March 2023
Actual Primary Completion Date February 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female, 21 - 45 years of age desiring permanent birth control
  • Agreement to use temporary birth control (excluding IUC) until documented occlusion
  • Sexually active (minimum of 4 coital acts per month) with male partner who is not known or suspected to be sterile
  • At low risk for sexually transmitted infection and / or monogamous
  • Reasonably certain subject is not pregnant at time of screening and procedure visits
  • Willing to accept the risk of pregnancy while relying solely on FemBloc for contraception
  • Signs informed consent agreeing to the protocol requirements and is able to meet the trial schedule

Exclusion Criteria:

  • Uncertainty about the desire to end fertility
  • Suspected or confirmed pregnancy
  • Prior tubal surgery
  • Uterine anomaly such as unicornuate, bicornuate, arcuate, septate, and didelphic
  • Known endometrial or myometrial conditions (e.g. submucous leiomyoma) or uterine position (e.g. retroflexion or anteflexion) that would interfere with insertion tube midline fundal placement, access to uterine cornua, or lateral deployment of the catheters
  • Any condition which may prohibit proper visualization of the cervix or not allow the uterus to be appropriately instrumented
  • Active or untreated pelvic infection
  • Presence or suspicion of gynecologic malignancy
  • Any condition or medical treatment (e.g. systemic corticosteroids or chemotherapy) that compromises immune system
  • Post-partum or pregnancy termination <6 weeks of scheduled procedure
  • Complicated IUC removal on the day of FemBloc treatment (e.g. use of intracavitary instrument for removal, bleeding, excessive pain)
  • Scheduled to undergo concomitant intrauterine procedures at the time of FemBloc treatment or planning any uterine procedure within the 3 months after treatment
  • Known hypersensitivity to cyanoacrylate or formaldehyde
  • Prior history of ectopic pregnancy
  • Abnormal uterine bleeding of unknown etiology
  • Any general health condition or systemic disease that may represent, in the Investigator's opinion, a potential increased risk associated with device use or pregnancy, or that would not allow them to complete the trial
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 NCT03067272
Other Study ID Numbers  ICMJE CP-100-006
Has Data Monitoring Committee No
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
Plan to Share IPD: No
Responsible Party Femasys Inc.
Study Sponsor  ICMJE Femasys Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director Sponsor Clinical Affairs
PRS Account Femasys Inc.
Verification Date October 2020

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