NCT00487552

Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction

Endoscopic Gastroenteric Anastomosis Formed by Magnetic Compression and Stent Placement for Palliation of Malignant Gastric Outlet Obstruction

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Cook Group Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if the Cook Magnetic Anastomosis Device can be used to safely and successfully create a patent gastrojejunal anastomosis in subjects requiring treatment of gastric outlet obstruction caused by malignancy.

Detailed description

Surgical treatments for malignant gastric outlet obstructions carry substantial risks and are associated with postoperative morbidity. External compression from advancing tumor or tissue growth through the stent can cause stenosis or re-obstruction. In these patients, the creation of a patent fistula that allows gastric emptying may significantly improve palliation. Minimally invasive techniques that carry no greater risks than enteral stenting may provide a viable palliative treatment. The primary objectives are safety, and successful creation of a gastro-jejunal anastomosis. Secondary objectives are successful resumption or improvement in the ability to tolerate PO feeding, rate of stent migration, and duration of stent and anastomosis patency.

Conditions

• Gastric Outlet Obstruction

Interventions

Type	Name	Description
DEVICE	Cook Magnetic Anastomosis Device (MAD) with Stent	Gastro-jejunal anastomosis

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-01-01
• Completion: 2011-04-01
• First posted: 2007-06-18
• Last updated: 2017-08-23
• Results posted: 2012-07-27

Locations

4 sites across 3 countries: Belgium, Italy, Netherlands