N/A N=60

Endostapler Hemostasis Study

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

Bottom Line

View on ClinicalTrials.gov: NCT04149925 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2020

Primary outcome: Primary: Staple Line Bleeding — 2.08; 2.57 score on a scale — p=0.01

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: AEON Endostapler (Device); Echelon Flex Powered Stapler (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Lexington Medical Inc.
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Staple Line Bleeding	2.08; 2.57	0.01 sig
SECONDARY Staple Line Leaking	0; 0; 30; 30	—
SECONDARY Adverse Events	0; 0; 30; 30	—
SECONDARY Product Malfunction	0; 0; 30; 30	—
SECONDARY Blood Transfusion	0; 0; 30; 30	—
SECONDARY Pain Level	1.8; 1.6	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04149925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.