NCT04273594进行中（未招募）不适用
BLOC: Prospective, Multi-Center, Study of Subjects Undergoing FemBloc Permanent Contraception With Two Confirmation Procedures (FemBloc With FemChec and Fluoro HSG)
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
- 45
- 试验地点
- 12
- 主要终点
- Concordance
研究概览
简要总结
The trial objectives include evaluating the adequacy of proposed mitigations for the previous pivotal trial of the FemBloc Permanent Contraceptive System and validating the confirmation procedure by comparing FemChec (ultrasound) to fluoroscopic hysterosalpingogram (fluoro HSG) for post-occlusion in the same patient.
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
- •Sexually active with male partner
- •Regular menstrual cycle for last 3 months or on hormonal contraceptives
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)
- •Allergy to shellfish, betadine or iodinated contrast
结局指标
主要结局
Concordance
时间窗: within 1 year
Concordance between FemBloc confirmation with FemChec and Fluoro HSG confirmation
Reliance Rate
时间窗: within 1 year
Number of subjects told to rely divided by number of qualified subjects
次要结局
未报告次要终点
研究者
研究点 (12)
Loading locations...
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