NCT05537727已完成不适用
Robotic Minimally Invasive Gynecological, Urological, and General Surgery With Dexter
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- occurrence of serious (Clavien - Dindo grades III-V), device related adverse events.
研究概览
简要总结
The purpose of this study is to confirm the perioperative and early postoperative safety and clinical performance of the Dexter Robotic System (Dexter Surgical System, Model DM-L6).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years
- •Patient agrees to perform the 30-day follow-up assessment
- •Able to provide signed Informed Consent, according to local regulation
排除标准
- •Morbidly obese patients.
- •Any and all relative and absolute contraindications to endoscopic surgical technique applicable to the use of conventional endoscopic surgical instruments.
- •Bleeding diathesis.
- •Pregnancy.
- •Patients with pacemakers or internal defibrillators.
- •Any planned concomitant procedures.
- •Patient deprived of liberty by administrative or judicial decision or under legal guardianship.
- •Participation in another interventional clinical trial.
结局指标
主要结局
occurrence of serious (Clavien - Dindo grades III-V), device related adverse events.
时间窗: perioperatively up to 30 days
successful completion of the Dexter-assisted procedure, i.e. free of any device related permanent conversion to an open or fully laparoscopic surgical approach.
时间窗: intraoperative
次要结局
未报告次要终点
研究者
研究点 (5)
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