Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction (MAD)

Cook Group

Status: Terminated

Conditions: Gastric Outlet Obstruction

Treatments: Device: Cook Magnetic Anastomosis Device (MAD) with Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00487552

06-014

900000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with unresectable malignancy with, or at risk of developing gastric outlet obstruction with GOOSS ≤ 2
• Karnofsky Performance Score ≥ 60

Exclusion criteria

• Patient is unable to understand and execute informed consent
• Age below 18 years
• Patients with any prior gastrointestinal surgery that significantly alters gastrojejunal anatomy
• Implanted cardiac pacemaker, defibrillator or ventricular assist device
• Requirement for chronic anticoagulation, or with uncorrectable coagulopathy
• Patients receiving chronic steroids or other drugs that may impair wound healing or formation of an intact anastomosis
• Simultaneously participating in another investigational drug or device
• Patients with suspicion of, or documented multiple small bowel strictures

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

1

Experimental group

Description:

palliative treatment of gastric outlet obstruction

Treatment:

Device: Cook Magnetic Anastomosis Device (MAD) with Stent