Device to Assist With Abdominal Access During Laparoscopic Surgery

NCT04392635 | Completed Results FDA Device

• 1 other identifier: IRB-55013
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• Surgeon Satisfaction Survey

  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)

  up to 1 minute on day of surgery

Secondary Outcomes (2)

• 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

Study Arms (2)

TauTona Pneumoperitoneum Assist Device (TPAD)

EXPERIMENTAL

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.

Device: TauTona Pneumoperitoneum Assist Device (TPAD)

Standard of Care (SOC)

ACTIVE COMPARATOR

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.

Procedure: Standard of Care (SOC)

Interventions

TauTona Pneumoperitoneum Assist Device (TPAD) DEVICE

The TPAD is an experimental device used to assist with placement of Veress needle during laparoscopic surgery.

TauTona Pneumoperitoneum Assist Device (TPAD)

Standard of Care (SOC) PROCEDURE

Standard of Care was used for Veress needle insertion.

Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• TauTona Group: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Study Team
• Organization: Stanford University

smeyer27@stanford.edu

650-723-6189

Study Officials

• James R Korndorffer Jr, MD MHPE FACS

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 19, 2020
• Study Start: June 20, 2022
• Primary Completion: June 17, 2024
• Study Completion: June 17, 2024
• Last Updated: July 1, 2025
• Results First Posted: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)