Endostapler Hemostasis Study

Lexington Medical Inc.60 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale

Interventions

AEON EndostaplerDEVICE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Avala Hospital

Covington, Louisiana, United States

Crescent City Surgical Centre

Metairie, Louisiana, United States

Southern Surgical Hospital

Slidell, Louisiana, United States

Outcomes

Primary Outcomes

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)

Time frame: 10 seconds after last staple line

Secondary Outcomes

Staple Line Leaking

Incidence of postoperative leakage during one-month monitoring period following procedure

Time frame: 1 month following procedure

Adverse Events

Incidence of reported device-related adverse events

Time frame: 1 month following procedure

Product Malfunction

Incidence of product malfunction during procedure

Time frame: During surgery

Blood Transfusion

Incidence of intraoperative or postoperative blood transfusion within 72 hours of surgery start time

Time frame: 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.

Time frame: 1 week following procedure