NCT03433911进行中（未招募）不适用
BLOC: Prospective Multi-Center Office Based Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Femasys Inc.
- 入组人数
- 240
- 试验地点
- 23
- 主要终点
- Incidence of short-term and long-term adverse events in each arm
研究概览
简要总结
Prospective, multi-center, international, non-randomized, two-arm study of subjects undergoing either FemBloc or laparoscopic bilateral tubal sterilization (Control). The FemBloc group total study duration will be approximately 65 months. The laparoscopic tubal sterilization (Control) group total study duration will be approximately 62 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Sexually active with male partner
- •For FemBloc Arm:
- •Regular menstrual cycle for last 3 months or on hormonal contraceptives
- •For Control Arm:
- •Undergoing planned laparoscopic bilateral tubal sterilization
排除标准
- •Uncertainty about the desire to end fertility
- •Known or suspected pregnancy
- •Prior tubal surgery, including sterilization attempt
- •Prior endometrial ablation
- •Presence, suspicion, or previous history of gynecologic malignancy
- •Abnormal uterine bleeding requiring evaluation or treatment
- •Scheduled to undergo concomitant intrauterine procedures at the time of procedure(s)
结局指标
主要结局
Incidence of short-term and long-term adverse events in each arm
时间窗: 1-5 years
Safety: Incidence of short-term and long-term adverse events in each arm
次要结局
未报告次要终点
研究者
研究点 (23)
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