NCT06473675已完成不适用
Hysterectomy With Adnexal Surgery Procedures With the DEXTER Robotic System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 5
- 主要终点
- primary performance endpoint
研究概览
简要总结
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged > 18 years
- •Patients planned to undergo elective robot-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease; using one camera port, two ports for the manipulating instruments, and additional ports as needed.
排除标准
- •Morbidly obese patients (BMI > 40)
- •Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
- •Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
- •Bleeding diathesis
- •Pregnancy
- •Patients with pacemakers or internal defibrillators
- •Any planned concomitant procedures
- •Patient deprived of liberty by administrative or judicial decision.
- •Participation in another interventional clinical trial
结局指标
主要结局
primary performance endpoint
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 endpoint
时间窗: up to 42 days
occurrence of Clavien - Dindo grades III-V adverse events
次要结局
未报告次要终点
研究者
研究点 (5)
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