NCT04392635

Device to Assist With Abdominal Access During Laparoscopic Surgery

Pilot Study to Establish Safety and Ease of Use of a TauTona Pneumoperitoneum Assist Device (TPAD) for Laparoscopic Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Laparoscopic Surgery

Interventions

Type	Name	Description
DEVICE	TauTona Pneumoperitoneum Assist Device (TPAD)	The TPAD is an experimental device used to assist with placement of Veress needle during laparoscopic surgery.
PROCEDURE	Standard of Care (SOC)	Standard of Care was used for Veress needle insertion.

Timeline

• Start date: 2022-06-20
• Primary completion: 2024-06-17
• Completion: 2024-06-17
• First posted: 2020-05-19
• Last updated: 2025-07-01
• Results posted: 2025-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study