NCT04392635已完成不适用
Pilot Study to Establish Safety and Ease of Use of a TauTona Pneumoperitoneum Assist Device (TPAD) for Laparoscopic Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Surgeon Satisfaction Survey
研究概览
简要总结
The purpose of this study is to assess the safety and ease of use of a TauTona Pneumoperitoneum Assist Device (TPAD) to assist with obtaining peritoneal access with a Veress needle, and for placing a primary trocar, during laparoscopic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >/= 18
- •Scheduled for laparoscopic surgery
- •Able to understand and willing to sign a written informed consent form
排除标准
- •Age < 18
- •Any situation where blind, peri-umbilical passage of a Veress needle is contraindicated.
- •Any situation where patients have suspected or confirmed intra-abdominal adhesions involving the peri-umbilical abdominal wall.
- •Any situation where patients have a suspected or confirmed umbilical hernia or peri-umbilical ventral hernia.
- •Any situation where there is not intact, uncompromised skin of the peri-umbilical region where the device is to be placed.
结局指标
主要结局
Surgeon Satisfaction Survey
时间窗: up to 1 minute on day of surgery
The surgeon completes a LIKERT scale satisfaction survey related to the TPAD to assess its ease of use. Scale range 1-5 (higher scores correspond to higher satisfaction)
次要结局
- Time From Incision for Veress Needle Insertion to Start of Insufflation(Up to approximately 2 minutes)
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0(Continuous from start of surgery through postoperative day 7)
研究者
研究点 (2)
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