NCT04392635CompletedNot Applicable
Pilot Study to Establish Safety and Ease of Use of a TauTona Pneumoperitoneum Assist Device (TPAD) for Laparoscopic Surgery
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Surgeon Satisfaction Survey
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age >/= 18
- •Scheduled for laparoscopic surgery
- •Able to understand and willing to sign a written informed consent form
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Surgeon Satisfaction Survey
Time Frame: 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)
Secondary Outcomes
- 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)
Investigators
Study Sites (2)
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