Endostapler Gastric Bypass Study

October 2, 2023 updated by: Lexington Medical Inc.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

25 subjects

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AEON Endostapler
Stapling performed with AEON Endostapler
Device: AEON Endostapler
Surgery with AEON Endostapler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of reported device-related adverse events
Time Frame: Within 30-day post-operative period
Within 30-day post-operative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic staple line bleeding
Time Frame: Within surgery
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)
Within surgery
Laparoscopic staple line bleeding
Time Frame: Within surgery
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)
Within surgery
Incidence of intraoperative or postoperative blood transfusion
Time Frame: Within 72 hours of surgery start time
Within 72 hours of surgery start time
Incidence of product malfunction
Time Frame: Within surgery
Within surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lexington Medical Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2021

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

January 13, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Endostapler03

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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