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

Completed

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT02358785

Run by

Ethicon Endo-Surgery

People needed

100

Starts

2015-01-01

Expected to finish

2015-11-01

Last updated by the study team

2017-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Surgical Specialists of Louisiana — Metairie, Louisiana, United States
• Carolinas Weight Management — Charlotte, North Carolina, United States
• Wake Forest School of Medicine — Winston-Salem, North Carolina, United States
• Greenville Health System — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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