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

Ethicon Endo-Surgery100 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Obesity

Interventions

ECHELON FLEX™ Powered Plus StaplerDEVICE

ECHELON FLEX™ Powered Plus Stapler using ENDOPATH ECHELON™ Reloads with Gripping Surface Technology (GST). The combination of stapler plus reload is referred to as the ECHELON FLEX™ GST System.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

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

Outcomes

Primary Outcomes

Surgical interventions (type, quantity, frequency, rationale) required during LSG

Time frame: Intraoperative

Secondary Outcomes

Procedure duration

Time frame: Up to one day

Length of stay

Time frame: Up to 4 weeks

Estimated blood loss

Time frame: up to one day

Data from ClinicalTrials.gov

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