Evaluation of a Powered Stapler System on Surgical Interventions Required During Laparoscopic Sleeve Gastrectomy

Status:	Completed
Conditions:	Obesity Weight Loss
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	18 - Any
Updated:	8/12/2017
Start Date:	January 1, 2015
End Date:	November 1, 2015

This study will provide clinical data in an observational setting. Individuals undergoing
LSG, and who meet study entry criteria, may be enrolled. LSG procedures will be performed
according to institutional standard-of-care (SOC) using the study stapler. All study subjects
will be followed for approximately 4 weeks for safety and outcomes.

Inclusion Criteria:

- Scheduled for laparoscopic sleeve gastrectomy;

- Subject meets NIH weight loss surgical criteria;

- BMI ≤ 60 kg/m2;

- Willing to give consent and comply with study-related evaluations; and

- At least 18 years of age

Exclusion Criteria:

- Previous bariatric procedures, including gastric banding;

- Prior gastric surgery;

- Scheduled concurrent surgical procedure (hiatal hernia repair, cholecystectomy
allowed);

- Pregnancy;

- Known or suspected uncontrolled bleeding disorders;

- History of chronic steroid use;

- Patients who have undergone significant upper GI surgery leading to adhesion;
formation, as determined by the Principal Investigator;

- Physical or psychological condition which would impair study participation;

- The patient is judged unsuitable for study participation by the Investigator for any
other reason; or

- Unable or unwilling to attend follow-up visits and examinations.

We found this trial at

sites

Greenville Health System

Greenville, South Carolina 29615

from

Greenville, SC