Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
NCT ID: NCT03067272
Last Updated: 2023-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2017-03-15
2023-03-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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FemBloc® Permanent Contraceptive System
Treatment of women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
45 Years
FEMALE
Yes
Sponsors
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Femasys Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Sponsor Clinical Affairs
Locations
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Altus Research Inc.
Lake Worth, Florida, United States
New York Presbyterian Hospital - Columbia University Medical Center
New York, New York, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Chattanooga Medical Research
Chattanooga, Tennessee, United States
Countries
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Other Identifiers
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CP-100-006
Identifier Type: -
Identifier Source: org_study_id
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