TauTona Pneumoperitoneum Assist Device (TPAD) (TPAD)

June 9, 2024 updated by: James Korndorffer, Stanford University
The purpose of this study is to assess the safety and ease of use of a trocar placement access device (TPAD) to assist with obtaining peritoneal access with a Veress needle, and for placing a primary trocar, during laparoscopic surgery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Stanford Hospital & Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Trocar Placement Assist Device (TPAD)
Participants will receive investigational TPAD device during laparoscopic surgery
Device: Trocar Placement Assist Device (TPAD)
The TPAD is an experimental device used to assist with placement of Veress needle and trocar during laparoscopic surgery.
Active Comparator: Standard of Care (SOC)
Standard of care 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.
Device: Trocar Placement Assist Device (TPAD)
The TPAD is an experimental device used to assist with placement of Veress needle and trocar during laparoscopic surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgeon satisfaction survey
Time Frame: 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)
up to 1 minute on day of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time required to obtain peritoneal access and place primary trocar during laparoscopic surgery
Time Frame: Up to 10 minutes
Time from incision to successful placement of primary trocar will be measured and reported
Up to 10 minutes
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 the surgery itself, or to the incision and skin around the incision where the TPAD is placed
Continuous from start of surgery through postoperative day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

TauTona Group

Investigators

  • Principal Investigator: James Korndorffer, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

June 17, 2024

Study Completion (Estimated)

June 17, 2024

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 9, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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