• Success rate and safety associated with the creation of a gastro-jejunal anastomosis using the Cook Magnetic Anastomosis Device. [ Time Frame: 8-14 days ] [ Designated as safety issue: Yes ]
• Trans-anastomotic deployment of a gastro-jejunal or duodenal stent. [ Time Frame: 10-14 days ] [ Designated as safety issue: Yes ]

• Improvement in ability to tolerate oral feeding [ Time Frame: 90-180 Days ] [ Designated as safety issue: No ]
• Rate of stent migration [ Time Frame: 90-180 Days ] [ Designated as safety issue: Yes ]
• Duration of patency of stent and gastro-jejunal anastomosis [ Time Frame: 90-180 Day ] [ Designated as safety issue: No ]

• Improvement in ability to tolerate oral feeding
• Rate of stent migration
• Duration of patency of stent and gastro-jejunal anastomosis

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.

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.

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
• Insulin dependent diabetes
• Thyroid disease

• MED Institute, Incorporated
• Cook Endoscopy