Device to Assist With Abdominal Access During Laparoscopic Surgery

Not Applicable

Completed

• Conditions: Laparoscopic Surgery
• Interventions: Device: TauTona Pneumoperitoneum Assist Device (TPAD); Procedure: Standard of Care (SOC)

• Registration Number: NCT04392635
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-19
• Study Start: 2022-06-20
• Primary Completion: 2024-06-17
• Study Completion: 2024-06-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age >/= 18
• Scheduled for laparoscopic surgery
• Able to understand and willing to sign a written informed consent form

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TauTona Pneumoperitoneum Assist Device (TPAD)	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.
Standard of Care (SOC)	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 Veresss needle was in the correct location (e.g. drop test), insufflation was initiated.

Primary Outcome Measures

Name	Time	Method
Surgeon satisfaction survey	up to 1 minute on day of surgery	The surgeon will complete 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 Outcome Measures

Name	Time	Method
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0	Continuous from start of surgery through postoperative day 7	Adverse events related to the surgery itself, or to the incision and skin around the incision where the TPAD is placed
Time required to obtain peritoneal access and place primary trocar during laparoscopic surgery	Up to 10 minutes	Time from incision to successful placement of primary trocar will be measured and reported

Trial Locations

Locations (1)

Shannon Meyer; 🇺🇸 Stanford, California, United States