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NCT04544865 · ClinicalTrials.gov registry record · NA
Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement
A NA study of Gastric Procedures and Lung Resection Procedures, sponsored by Ethicon Endo-Surgery.
- Completed
- Registry status
- NA
- Development phase
- 240
- Enrollment target
- 8
- Study locations
NCT04544865: Completed NA study of Gastric Procedures and Lung Resection Procedures, sponsored by Ethicon Endo-Surgery.
NCT04544865 is a NA study of Gastric Procedures and Lung Resection Procedures that has completed, run by Ethicon Endo-Surgery. The registered enrollment target is 240 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04544865, a NA study of Gastric Procedures and Lung Resection Procedures, has completed, sponsored by Ethicon Endo-Surgery.
- COMPLETED
- Registry status
- NA
- Development phase
- 240 participants
- Enrollment target
- 8
- Study locations
Study 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.
Primary Outcome
Number of participants who experienced specific device-related AEs post gastric resection procedures was reported. Specific device-related AEs were bleeding (defined as occurrence of post-surgery blood transfusion deemed related to bleeding at the staple line or return to surgery room before 70-day post-surgery follow-up visit due to bleeding deemed related to the staple line), leak (defined as occurrence of intra-surgery or post-surgery gastrointestinal leak related to the staple line as docume
Conditions Studied
Interventions
- DEVICE Staple Line Reinforcement
Study Locations (8)
Michigan
- Henry Ford Health System - Detroit
- Spectrum Health - Grand Rapids
Indiana
- Indiana University Health - Indianapolis
Louisiana
- Our Lady of the Lake Regional Medical Center - Baton Rouge
Missouri
- University of Missouri - Columbia
New York
- Long Island Jewish Medical Center - New York
North Carolina
- Atrium Health - Charlotte
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2020-09-29 |
| Est. Completion | 2023-02-08 |
| Phase | NA |
What the finished NCT04544865 record still lists
NCT04544865 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with Gastric Procedures appearing as the primary indexed condition, and to 1 intervention - of which Staple Line Reinforcement is the first listed.
NCT04544865 lists 8 locations in 7 states (Michigan, Indiana, Louisiana).
Frequently Asked Questions
What is clinical trial NCT04544865 about?
NCT04544865 is a clinical study titled "Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement". 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 ...
What is the current status of trial NCT04544865?
This trial is currently completed. It is a NA study. The enrollment target is 240 participants. The study started on 2020-09-29. Estimated completion is 2023-02-08.
What conditions does trial NCT04544865 study?
This clinical trial studies the following conditions: Gastric Procedures, Lung Resection Procedures.
What interventions are being tested in trial NCT04544865?
The interventions under investigation include: Staple Line Reinforcement (DEVICE).
Who is sponsoring clinical trial NCT04544865?
This trial is sponsored by Ethicon Endo-Surgery, which has 39 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04544865 being conducted?
This trial has 8 study locations across Indiana, Louisiana, Michigan, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04544865's enrollment target sits among peer trials
240 440th of 2000 higher than 1,542 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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