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

Completed

• Conditions: Obesity

• Registration Number: NCT02358785
• Lead Sponsor: Ethicon Endo-Surgery

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2015-01-30
• Study First Submitted QC: 2015-02-03
• Study First Posted: 2015-02-09
• Primary Completion: 2015-10-01
• Study Completion: 2015-11-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-10
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surgical interventions (type, quantity, frequency, rationale) required during LSG	Intraoperative

Secondary Outcome Measures

Name	Time	Method
Procedure duration	Up to one day
Length of stay	Up to 4 weeks
Estimated blood loss	up to one day

Trial Locations

Locations (4)

Surgical Specialists of Louisiana; 🇺🇸 Metairie, Louisiana, United States

Greenville Health System; 🇺🇸 Greenville, South Carolina, United States

Carolinas Weight Management; 🇺🇸 Charlotte, North Carolina, United States

Wake Forest School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States