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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