Trial ID or NCT#

NCT01024296

Status

NOT RECRUITING

Purpose

During any minimally invasive surgery case, 5-25mm size incisions need to be made to gain access to the abdomen. One of the most difficult, time-consuming, and sometimes unreliable parts of the case is closing these incisions, especially in obese patients. This is mainly because these incisions are very small and the layer that needs to be closed (fascia) rests deep underneath the skin and fat tissue of the abdominal wall. Two of the investigators (CM and BS) have developed at Stanford an instrument that allows for an easier and more reliable closure of these wounds. The purpose of this study is to test this instrument in the closure of laparoscopic wounds in obese patients undergoing laparoscopic gastric bypass surgery.

Official Title

Pivotal Study to Evaluate the Efficacy of a Laparoscopic Port Closure Device

Eligibility Criteria

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes

Investigator(s)

Thomas M. Krummel, MD, FACS/FAAP
Emile Holman Professor, Susan B. Ford Surgeon-in-Chief at LPCH, and Professor, by courtesy, of Cardiothoracic Surgery and of Bioengineering

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CONTACT

Bilal M Shafi, MD
(215) 738-0400