NCT04149925

Endostapler Hemostasis Study

Completed Results posted Last updated 23 February 2021

What this trial tests

trial testing AEON Endostapler in Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale in 60 participants. Completed in 14 February 2020.

Timeline

22 October 2019

Primary endpoint
24 January 2020

14 February 2020

Quick facts

Lead sponsor	Lexington Medical Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	60
Start date	22 October 2019
Primary completion	24 January 2020
Estimated completion	14 February 2020
Sites	3 locations across United States

Drugs / interventions tested

• AEON Endostapler
• Echelon Flex Powered Stapler

Conditions studied

• Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale — all drugs for Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale →

Sponsor

Lexington Medical Inc.

Who can join

18 and older, any sex, with Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Staple Line Bleeding Primary · 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)

Group	Value	95% CI
AEON Endostapler	2.08	± .98
Echelon Flex Powered Stapler	2.57	± 1.13

Staple Line Leaking Secondary · 1 month following procedure

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

Group	Value	95% CI
AEON Endostapler	0
Echelon Flex Powered Stapler	0
AEON Endostapler	30
Echelon Flex Powered Stapler	30

Adverse Events Secondary · 1 month following procedure

Incidence of reported device-related adverse events

Group	Value	95% CI
AEON Endostapler	0
Echelon Flex Powered Stapler	0
AEON Endostapler	30
Echelon Flex Powered Stapler	30

Product Malfunction Secondary · During surgery

Incidence of product malfunction during procedure

Group	Value	95% CI
AEON Endostapler	0
Echelon Flex Powered Stapler	0
AEON Endostapler	30
Echelon Flex Powered Stapler	30

Blood Transfusion Secondary · Within 72 hours of surgery start

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

Group	Value	95% CI
AEON Endostapler	0
Echelon Flex Powered Stapler	0
AEON Endostapler	30
Echelon Flex Powered Stapler	30

Pain Level Secondary · 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.

Group	Value	95% CI
AEON Endostapler	1.8	± 2.9
Echelon Flex Powered Stapler	1.6	± 2.7

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.