Endostapler Sleeve Gastrectomy Study

A Randomized Study Comparing Endostaplers in Sleeve Gastrectomy

The goal of this prospective, post-market study is to measure AEON™ Endostapler performance for laparoscopic sleeve gastrectomy surgery versus the Endo GIA™ Reloads with Tri-Staple™ Technology from Medtronic.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Device: AEON Endostapler; Device: Endo GIA Reloads with Tri-Staple Technology

Detailed Description

Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding from endoscopic images, evaluated by a blinded third-party. The study will include 60 total consecutive cases of individuals undergoing a planned laparoscopic sleeve gastrectomy (LSG). The LSG 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
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Holyoke, Massachusetts, United States, 01040
      • Holyoke Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

60 subjects

Description

Inclusion Criteria:

• Patients undergoing planned laparoscopic sleeve gastrectomy
• 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 Partial Thromboplastin Time (PTT) >45sec, or Prothrombin Time (PT) >15sec, or International Normalized Ratio (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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AEON Endostapler; Stapling performed with AEON Endostapler	Device: AEON Endostapler; Surgery with AEON Endostapler
Endo GIA Reloads with Tri-Staple Technology; Stapling performed with Endo GIA Reloads with Tri-Staple Technology	Device: Endo GIA Reloads with Tri-Staple Technology; Surgery with Endo GIA Reloads with Tri-Staple Technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Endoscopic Staple Line Bleeding Score	Intraoperative staple line bleeding score from endoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome.	Within surgery, after the last stapler firing
Intraoperative Laparoscopic Staple Line Bleeding Score	Intraoperative staple line bleeding score from laparoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome.	Within surgery, images captured 10 seconds after the last stapler firing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Postoperative Leakage Requiring Intervention	Number of participants with postoperative leakage requiring intervention	Within 30-day post-operative period
Number of Participants With Intraoperative or Postoperative Blood Transfusion	Number of participants with intraoperative or postoperative blood transfusion	Within 72 hours of surgery start time
Number of Participants With Reported Device-related Adverse Events	Number of participants with reported device-related adverse events	Within 30-day post-operative period
Number of Participants With Product Malfunction	Number of participants with product malfunction. Product malfunction means any occurrence during the surgery where the stapler does not perform as intended.	Within surgery

Collaborators and Investigators

• Sponsor: Lexington Medical Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): June 10, 2021
• Study Completion (Actual): July 10, 2021

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Endostapler02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes