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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Device: ECHELON FLEX™ Powered Plus Stapler

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • Surgical Specialists of Louisiana
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Weight Management
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest School of Medicine
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals scheduled for laparoscopic sleeve gastrectomy

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Surgical interventions (type, quantity, frequency, rationale) required during LSG	Intraoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Procedure duration	Up to one day
Length of stay	Up to 4 weeks
Estimated blood loss	up to one day

Collaborators and Investigators

• Sponsor: Ethicon Endo-Surgery
• Investigators: Principal Investigator: Adolfo Fernandez, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: January 30, 2015
• First Submitted That Met QC Criteria: February 3, 2015
• First Posted (Estimate): February 9, 2015

Study Record Updates

• Last Update Posted (Actual): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 10, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: ESC-14-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: via publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes