Device to Assist With Abdominal Access During Laparoscopic Surgery

Stanford University31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Laparoscopic Surgery

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Stanford University

Stanford, California, United States

Outcomes

Primary Outcomes

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)

Time frame: up to 1 minute on day of surgery

Secondary Outcomes

Time From Incision for Veress Needle Insertion to Start of Insufflation

Time frame: Up to approximately 2 minutes

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

Adverse events related to use of the TPAD device

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

Data from ClinicalTrials.gov

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