Gastric Tissue Stapler Comparison Study

Completed

Conditions studied: Gastric Resection

In brief

This study is conducted to compare performance characteristics of staple lines resecting the stomach in excised human gastric tissue with existing Echelon Flex Powered Plus GST System (Ethicon, size: 60mm, "Echelon") stapler and the Titan SGS (Standard Bariatrics, "Titan"). The Study is a single center clinical trial, randomized (1:1, Arm A - Ethicon Echelon 60 application, Arm B - Standard Bariatrics Titan SGS application) which utilizes the excised stomach tissue from up to 75 adults undergoing laparoscopic sleeve gastrectomy (LSG). This study will be conducted in the USA.

Key facts

Study ID

NCT04086433

Run by

Standard Bariatrics

People needed

36

Starts

2019-07-15

Expected to finish

2019-10-30

Last updated by the study team

2020-06-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Laparoscopic sleeve gastrectomy patients at study site, ages 18 to 80

You may not qualify if…

• Prior gastric surgery (lap band, Nissen fundoplication, G tube, greater curve plication, etc.)
• Gastric lesion recognized during surgery (entire specimen would be sent to pathology)
• Stomach damaged during extraction

Where it is running

• University at Buffalo — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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