Device to Assist With Abdominal Access During Laparoscopic Surgery

Overview

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.

Full Title of Study: “Pilot Study to Establish Safety and Ease of Use of a Trocar Placement Access Device (TPAD) for Laparoscopic Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Device Feasibility
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 1, 2023

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Trocar Placement Assist Device (TPAD)
    • Participants will receive investigational TPAD device during laparoscopic surgery

Clinical Trial Outcome Measures

Primary Measures

  • 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)

Secondary Measures

  • 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
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Stanford University
  • Collaborator
    • TauTona Group
  • Provider of Information About this Clinical Study
    • Principal Investigator: James Korndorffer, Associate Professor of Surgery (General Surgery) – Stanford University
  • Overall Official(s)
    • James R Korndorffer Jr, MD MHPE FACS, Principal Investigator, Stanford University

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