Endostapler Hemostasis Study

Completed

• Conditions: Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale
• Interventions: Device: AEON Endostapler; Device: Echelon Flex Powered Stapler

• Registration Number: NCT04149925
• Lead Sponsor: Lexington Medical Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-22
• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-11-01
• Study First Posted: 2019-11-04
• Primary Completion: 2020-01-24
• Study Completion: 2020-02-14
• Results First Submitted: 2020-03-04
• Results First Submitted QC: 2020-03-28
• Results First Posted: 2020-04-08
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AEON Endostapler	AEON Endostapler	Stapling performed by AEON Endostapler
Echelon Flex Powered Stapler	Echelon Flex Powered Stapler	Stapling performed by Echelon Flex Powered Stapler

Primary Outcome Measures

Name	Time	Method
Staple Line Bleeding	10 seconds after last staple line	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)

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Avala Hospital; 🇺🇸 Covington, Louisiana, United States

Crescent City Surgical Centre; 🇺🇸 Metairie, Louisiana, United States

Southern Surgical Hospital; 🇺🇸 Slidell, Louisiana, United States