CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 240 enrolled
Drug / intervention
Staple Line Reinforcementdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04544865
NCT04544865N/ACompleted
CompareCT.gov

A Prospective, Single-Arm, Multi-Center Study of the ECHELON ENDOPATH(TM) Staple Line Reinforcement Device in Gastric and Lung Resection Procedures

Ethicon Endo-Surgery·interventional·Posted Sep 10, 2020·Updated Dec 5, 2023

In Brief

A clinical study evaluating Staple Line Reinforcement for Gastric Procedures and Lung Resection Procedures. Completed, enrolled 240 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Procedures, Lung Resection Procedures
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 10, 2020
Enrollment StartSep 29, 2020
Primary CompletionOct 17, 2022
Study CompletionFeb 8, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.8 years ago

Interventions

Staple Line Reinforcementdevice

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