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

Ethicon

Status: Completed

Conditions: Obesity

Treatments: Device: ECHELON FLEX™ Powered Plus Stapler

Study type: Observational

Funder types: Industry

Identifiers

NCT02358785

ESC-14-005

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.