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Trial record 2 of 2 for:    fembloc

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 : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Femasys Inc.

Brief Summary:
Prospective, multi-center, pilot study to evaluate the safety of the FemBloc™ Permanent Contraceptive System for female sterilization in preventing pregnancy.

Condition or disease Intervention/treatment Phase
Contraception Device: FemBloc® Permanent Contraceptive System Not Applicable

Detailed Description:
Prospective, multi-center, pilot study of subjects undergoing the FemBloc Permanent Contraceptive System procedure to be conducted at up to 5 sites in the U.S. enrolling up to 50 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. Following the pilot safety endpoint analysis at 3-month follow-up, Femasys intends to continue follow-up of pilot subjects for a total duration of approximately 68 months after the FemBloc treatment procedure.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
Actual Study Start Date : February 24, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FemBloc® Permanent Contraceptive System
Treatment of women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes.
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).




Primary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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

  2. 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



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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
  • 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

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): NCT03067272


Locations
United States, Connecticut
The Stamford Hospital
Stamford, Connecticut, United States, 06904
United States, Florida
QPS Miami Research
South Miami, Florida, United States, 33143
United States, New York
New York Presbyterian Hospital - Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Tennessee
Chattanooga Medical Research
Chattanooga, Tennessee, United States, 37404
Sponsors and Collaborators
Femasys Inc.
Investigators
Study Director: Study Director Sponsor Clinical Affairs

Responsible Party: Femasys Inc.
ClinicalTrials.gov Identifier: NCT03067272     History of Changes
Other Study ID Numbers: CP-100-006
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs