Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction — MAD  

Gastric Outlet Obstruction Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gastric Outlet Obstruction
• Pyloric Stenosis

• NCT number: NCT00487552
• Study type: Interventional
• Source: Cook
• Status: Terminated
• Phase: Phase 1
• Start date: January 2008
• Completion date: April 2011