Pilot Study to Establish Safety and Ease of Use of a TauTona Pneumoperitoneum Assist Device (TPAD) for Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 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.
研究组 & 干预措施
TauTona Pneumoperitoneum Assist Device (TPAD)
Participants will receive investigational TPAD device during laparoscopic surgery. The TPAD was used to aid Veress needle insertion in place of surgical tools such as clamps. The TPAD was applied to the patient prior to Veress needle entry and removed after insufflation was completed.
干预措施: TauTona Pneumoperitoneum Assist Device (TPAD) (Device)
Standard of Care (SOC)
Participants will receive SOC included both direct (unassisted) entry and assisted entry using clamps, if needed, to aid in Veress needle insertion. Upon confirmation that the Veress needle was in the correct location (e.g. drop test), insufflation was initiated.
干预措施: Standard of Care (SOC) (Procedure)
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
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0(Continuous from start of surgery through postoperative day 7)
- Time From Incision for Veress Needle Insertion to Start of Insufflation(Up to approximately 2 minutes)