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OpenTrials
Completed

NCT Number: NCT04392635

Device to Assist With Abdominal Access During Laparoscopic Surgery

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.

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Key information

Conditions

Laparoscopic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TauTona Pneumoperitoneum Assist Device (TPAD)

Device

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

Standard of care (SoC)

Procedure

Standard of Care was used for Veress needle insertion.

Primary outcomes

  1. 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

  1. Time From Incision for Veress Needle Insertion to Start of Insufflation

    Time frame: Up to approximately 2 minutes

  2. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

    Time frame: Continuous from start of surgery through postoperative day 7

    Adverse events related to use of the TPAD device

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • TauTona Group

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 19, 2020
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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