NCT05945433招募中不适用
Anovo™ Surgical System - Registry Study
Momentis Surgical1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年6月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Rate of Unanticipated Adverse Device Effect
研究概览
简要总结
To collect Real-World Data (RWD) on the ongoing safety and effectiveness of the anovo Surgical system in transvaginal gynecological laparoscopic surgical procedures and to obtain information on the impact of the anovo Skills Development Pathway on user behavior and performance (where performance is measured by the learning curve of the surgeons and procedure outcomes).
详细描述
Specific Aims:
- To collect RWD from surgeons with varying experience and expertise on their learning curve and time to achieve competency, and as such assess the success of the Skills Development Pathway.
- Collect safety information and analyze the causality between type and frequency of adverse events to surgeons' experience.
- Evaluate the effectiveness of the device while minimizing bias by enrolling "all comers", which will represent the general patient population.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •patients must understand and sign the informed consent form, including data privacy authorization, indicating their consent to participate in the registry study.
- •willing to complete post-operative questionnaire
排除标准
- 未提供
结局指标
主要结局
Rate of Unanticipated Adverse Device Effect
时间窗: 8 Weeks Follow Up
Conversion rate to open or laparoscopic approach
时间窗: Procedure
次要结局
- Surgery time (minutes)(Procedure)
研究者
研究点 (1)
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