Prospective, Monocentric, Single Arm, Observational PMCF - Study on the Performance and Safety of Double-Shank Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Rate of slippage / movement of the clip in relationship to the total number of used clips.
研究概览
简要总结
Prospective, monocentric, single arm, observational PMCF - Study on the Performance and Safety of Double-Shank Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)
详细描述
The objective of this observational study is to collect systematically and proactively data regarding the Aesculap® DS Titanium Ligation Clip under daily clinical practice when used in urology in different indications.
The hypothesis of this study is that this event, slippage / movement of the clip, is extremely rare through the design if used in accordance with the Instructions for Use (IfU). The observed rate through the total number of clips might be a valuable parameter and could influence future research.
Furthermore, this study is one of the PMCF measures which enable the manufacturer to monitor the safety and performance of the Aesculap® DS Titanium Ligation Clips. The products bear the CE-marking and are routinely used within this institution for the above-mentioned procedures.
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
- •Planned Da Vinci radical prostatectomy using DS Titanium Ligation Clips (according to the IfU) - OR
- •Planned laparoscopic nephrectomy using Titanium Ligation Clip (according to the IfU) - OR
- •Planned Da Vinci partial nephrectomy using Titanium Ligation Clip (according to the IfU)
- •Patient's written informed consent
- •Age ≥ 18 years
- •Intraoperative Usage of DS Titanium Ligation Clips (according to the IfU)
排除标准
- 未提供
结局指标
主要结局
Rate of slippage / movement of the clip in relationship to the total number of used clips.
时间窗: Intraoperatively
Slippage / movement of the Aesculap® DS Titanium Ligation Clip is an observable slippage, movement, or rotation after the clip was successfully applied and the application forceps was removed. The number of observed slippage / movement of the clip will be documented on the CRF, the clip size, step of the procedure and further measures were necessary, i.e. removal of the clip or application of another clip, will be documented. In the end the rate will be brought in relationship to the overall number of applied clips. Thus, the number of applied clips is documented, for each clip size.
次要结局
- Rate of Adverse events (intra- and postoperative)(up to discharge from hospital (approximately 10 days post surgery))