Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception

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