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Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement

NCT04544865 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2023-12-05

Study results available
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Summary

This prospective, single-arm, multi-center evaluation will collect clinical data in a post-market setting. The two types of procedures studied will be gastric and thoracic. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ECHELON ENDOPATH Staple Line Reinforcement instructions for use.

Conditions

  • Gastric Procedures
  • Lung Resection Procedures

Interventions

DEVICE

Staple Line Reinforcement

ENDOPATH ECHELON Staple Line Reinforcement is used for reinforcement of staple lines during lung resection and bariatric surgical procedures, according to instructions for use.

Sponsors & Collaborators

  • Ethicon Endo-Surgery

    lead INDUSTRY

Principal Investigators

  • Andrew Popoff, MD · Henry Ford Health System

  • David Zeltsman, MD · Long Island Jewish Medical Center

  • Andrew Wheeler, MD · University of Missouri-Columbia

  • Jon Schram, MD · Spectrum Health Hospitals

  • Kenneth Kesler, MD · Indiana University Health

  • Emily Cassidy, MD · Our Lady of the Lake Hospital

  • Keith Gersin, MD · Wake Forest University Health Sciences

  • Linda Martin, MD · University of Virginia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-29
Primary Completion
2022-10-17
Completion
2023-02-08
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 NCT04544865 on ClinicalTrials.gov