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Endostapler Hemostasis Study

NCT04149925 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2021-02-23

Study results available
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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.

Conditions

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

Interventions

DEVICE

AEON Endostapler

Surgery with AEON Endostapler

DEVICE

Echelon Flex Powered Stapler

Surgery with Echelon Flex Powered Stapler

Sponsors & Collaborators

  • Surgical Specialists of Louisiana

    collaborator OTHER

  • Lexington Medical Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-22
Primary Completion
2020-01-24
Completion
2020-02-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04149925 on ClinicalTrials.gov