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Endostapler Gastric Bypass Study | Clinical Trials | Clareo Health

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Endostapler Gastric Bypass Study

Safety and Efficacy of the AEON™ Endostapler in Laparoscopic Roux-en-Y Gastric Bypass Surgery

NCT04712526•Lexington Medical Inc.

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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

Key Dates

Start Date

January 18, 2021

Primary Completion Date

November 1, 2023

Completion Date

December 1, 2023

Last Updated

October 4, 2023

Conditions

Obesity

Interventions

AEON Endostapler

DEVICE

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 4, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Endostapler Gastric Bypass Study

Inclusion Criteria

Exclusion Criteria

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

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