Trial Search Results

Efficacy Study to Evaluate Laparoscopic Fascial Closure Device

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: SurgSolutions, LLC

Stanford Investigator(s):

Intervention(s):

  • Device: Port Close

Phase:

N/A

Eligibility


Inclusion Criteria:- Clinical Diagnosis of Morbid Obesity

   - BMI > 40 or BMI > 35 with medical comorbidities

   - Undergoing laparoscopic gastric surgery

   - Have at least one trocar site measuring 12 mm or greater Exclusion Criteria:Vulnerable
   subjects will be excluded including:

      1. Children

      2. Pregnant women

      3. Economically and educationally disadvantaged

      4. Decisionally impaired

      5. Homeless people

      6. Employees and students.

Ages Eligible for Study

18 Years - 65 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Bilal M Shafi, MD
215-738-0400
Recruiting