Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Femasys Inc.
- 入组人数
- 49
- 试验地点
- 9
- 主要终点
- Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc treatment procedure
研究概览
简要总结
Prospective, multi-center, pilot study evaluating the safety of the FemBloc® Permanent Contraceptive System for female sterilization in preventing pregnancy.
详细描述
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 study was to evaluate the safety of the FemBloc Permanent Contraceptive System for female sterilization in preventing pregnancy. Femasys continued follow-up of pilot subjects for safety a total duration of approximately 68 months after the FemBloc treatment procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
FemBloc® Permanent Contraceptive System
Treatment of women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes.
干预措施: FemBloc® Permanent Contraceptive System (Device)
结局指标
主要结局
Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc treatment procedure
时间窗: 5 months
Evaluated up to 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 System (Blended Polymer Treatment and Confirmation Test)
时间窗: 3 months (pilot study safety endpoint and then through 5 years)
Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc System. Evaluated up to 3 months after the FemBloc Treatment and Confirmation Test (device and/or procedure related AEs) and then through 5 years.
次要结局
未报告次要终点