NCT04544865

Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Ethicon Endo-Surgery · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study is to prospectively generate clinical data on device-related adverse events in a post-market setting using ECHELON ENDOPATH Staple Line Reinforcement per its instructions for use. There will be no blinding in this study. An interim analysis is planned for sample-size re-estimation.

Conditions

• Gastric Procedures
• Lung Resection Procedures

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-29
• Primary completion: 2022-10-17
• Completion: 2023-02-08
• First posted: 2020-09-10
• Last updated: 2023-12-05
• Results posted: 2023-12-05

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study