Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Primary safety outcome
研究概览
简要总结
The purpose of this post-market, observational study is to collect data under anticipated conditions of use that demonstrates that DEXTER performs as intended in the intended patient population, including a variety of representative disease etiologies and demographic groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥ 22 years of age at time of enrollment/consent
- •Subject is indicated for and planned to undergo robot-assisted and laparoscopic surgery for unilateral or bilateral inguinal hernia repair
- •Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form
排除标准
- •Subject with any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments and/or general non-procedure specific contraindications to endoscopic surgery including bleeding diathesis and pregnancy
- •Subject is participating in another clinical investigation at the time of enrollment or planned participation at any time during this clinical study
- •Subject has a known or suspected medical condition that, in the opinion of the Investigator, may put the subject at risk for participation in this clinical study
结局指标
主要结局
Primary safety outcome
时间窗: up to 30 days after surgery
Occurrence of Clavien-Dindo grades III-V adverse events
Primary efficacy outcome
时间窗: Intraoperative
Successful completion of the DEXTER-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach
Primary safety outcome
时间窗: up to 30 days after surgery
Occurrence of Clavien-Dindo grades III-V adverse events
Primary efficacy outcome
时间窗: Intraoperative
Successful completion of the DEXTER-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach
次要结局
未报告次要终点