Endostapler Hemostasis Study

Improving Hemostasis in Sleeve Gastrectomy With Alternative Stapler

The goal of this prospective, multi-center, post-market study is to measure AEON™ Endostapler performance with the EASY/THICK MODE feature for laparoscopic bariatric surgery against the Echelon Flex™ Powered Stapler system from Ethicon. Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding through a third-party blinded primary outcome evaluator. 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. Relevant data will be collected using the Data Collection sheet which should be filled out following each procedure by a member of the surgical or nursing team.

Study Overview

• Status: Completed
• Conditions: Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale
• Intervention / Treatment: Device: AEON Endostapler; Device: Echelon Flex Powered Stapler

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Avala Hospital
    • Metairie, Louisiana, United States, 70001
      • Crescent City Surgical Centre
    • Slidell, Louisiana, United States, 70458
      • Southern Surgical Hospital

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

See above

Description

Inclusion Criteria:

• Patients undergoing planned laparoscopic sleeve gastrectomy with signed surgery consent form
• Informed consent for study obtained and signed from each subject

Exclusion Criteria:

• Planned open surgical approach
• Prior bariatric operation (i.e. revisional bariatric surgery)
• Use of staple line reinforcement material (buttress)
• Patients taking anticoagulants
• Patients under the age of 18 on the date of the surgery

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 by AEON Endostapler	Device: AEON Endostapler; Surgery with AEON Endostapler
Echelon Flex Powered Stapler; Stapling performed by Echelon Flex Powered Stapler	Device: Echelon Flex Powered Stapler; Surgery with Echelon Flex Powered Stapler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Staple Line Bleeding	Intraoperative staple line bleeding as measured by the provided bleeding severity scale (1: No bleeding; 2: Minimal bleeding; 3: Moderate bleeding; 4: Excessive bleeding; 5: Profuse bleeding)	10 seconds after last staple line

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Staple Line Leaking	Incidence of postoperative leakage during one-month monitoring period following procedure	1 month following procedure
Adverse Events	Incidence of reported device-related adverse events	1 month following procedure
Product Malfunction	Incidence of product malfunction during procedure	During surgery
Blood Transfusion	Incidence of intraoperative or postoperative blood transfusion within 72 hours of surgery start time	Within 72 hours of surgery start
Pain Level	Postoperative pain level as measured by a standard pain severity scale of 0-10 where 0 means no pain and 10 means severe pain.	1 week following procedure

Collaborators and Investigators

• Sponsor: Lexington Medical Inc.
• Collaborators: Surgical Specialists of Louisiana

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2019
• Primary Completion (Actual): January 24, 2020
• Study Completion (Actual): February 14, 2020

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: Endostapler01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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