Endostapler Gastric Bypass Study

Lexington Medical Inc.

Overview

The goal of this prospective, post-market study is to evaluate safety and efficacy of the AEON™ Endostapler when used in laparoscopic Roux-en-Y gastric bypass surgery.

Stapler performance will be evaluated by incidence and degree of staple line bleeding from endoscopic and laparoscopic images, evaluated by a third-party. The study will include 25 total consecutive cases of individuals undergoing a planned laparoscopic Roux-en-Y gastric bypass (GB). The GB procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care.

Study Type

OBSERVATIONAL

Conditions

Obesity

Interventions

AEON EndostaplerDEVICE

Surgery with AEON Endostapler

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients undergoing planned laparoscopic Roux-en-Y gastric bypass * Informed consent for study obtained and signed from each subject Exclusion Criteria: * Planned open surgical approach * Use of staple line reinforcement material (buttress) * Revision or other bariatric procedure * Patients with a bleeding disorder: known coagulopathy, or Platelets \<100,000, or PTT \> 45sec, or PT\> 15sec, or INR\>1.5 * Patients with active HIV or Hepatitis B * Patients under the age of 18 on the date of the surgery * Patients who are pregnant * Patients using tobacco products within the last 2 weeks prior to surgery date * Patients using cortisone or related products within the last 2 weeks prior to surgery date

Locations (1)

Holyoke Medical Center

Holyoke, Massachusetts, United States

Outcomes

Primary Outcomes

Incidence of reported device-related adverse events

Time frame: Within 30-day post-operative period

Secondary Outcomes

Endoscopic staple line bleeding

Incidence of intraoperative staple line bleeding from endoscopic images as measured by the provided bleeding severity scale - Bleeding Severity Scale for Endoscope Images (1: No bleeding, 5: Profuse Bleeding)

Time frame: Within surgery

Laparoscopic staple line bleeding

Incidence of intraoperative staple line bleeding from laparoscopic images as measured by the provided bleeding severity scale - Bleeding Severity Scale for Laparoscope Images (1: No bleeding, 5: Profuse Bleeding)

Time frame: Within surgery

Incidence of intraoperative or postoperative blood transfusion

Time frame: Within 72 hours of surgery start time

Incidence of product malfunction

Time frame: Within surgery

Data from ClinicalTrials.gov

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