Status:
COMPLETED
Device to Assist With Abdominal Access During Laparoscopic Surgery
Lead Sponsor:
Stanford University
Collaborating Sponsors:
TauTona Group
Conditions:
Laparoscopic Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Age \>/= 18
- Scheduled for laparoscopic surgery
- Able to understand and willing to sign a written informed consent form
Exclusion
- 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.
Key Trial Info
Start Date :
June 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2024
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04392635
Start Date
June 20 2022
End Date
June 17 2024
Last Update
July 1 2025
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94304