Completed

NCT Number: NCT04149925

Endostapler Hemostasis Study

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Avala Hospital, Covington, Louisiana, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AEON Endostapler

Device

Surgery with AEON Endostapler

Echelon Flex Powered Stapler

Device

Surgery with Echelon Flex Powered Stapler

Primary outcomes

Staple Line Bleeding

Time frame: 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 outcomes

Staple Line Leaking

Time frame: 1 month following procedure

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

Time frame: 1 month following procedure

Incidence of reported device-related adverse events
Product Malfunction

Time frame: During surgery

Incidence of product malfunction during procedure
Blood Transfusion

Time frame: Within 72 hours of surgery start

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Lexington Medical Inc.

Industry

Collaborators

Surgical Specialists of Louisiana

Registry information

Official study title

Improving Hemostasis in Sleeve Gastrectomy With Alternative Stapler

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Nov 4, 2019
Registry last updated: Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.