MedTrace Logo

Device to Assist With Abdominal Access During Laparoscopic Surgery

NCT04392635 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-07-01

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Laparoscopic Surgery

Interventions

DEVICE

TauTona Pneumoperitoneum Assist Device (TPAD)

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

PROCEDURE

Standard of Care (SOC)

Standard of Care was used for Veress needle insertion.

Sponsors & Collaborators

Principal Investigators

  • James R Korndorffer Jr, MD MHPE FACS · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-20
Primary Completion
2024-06-17
Completion
2024-06-17
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04392635 on ClinicalTrials.gov