Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction

NCT ID: NCT00487552

Last Updated: 2017-08-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-04-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

1

palliative treatment of gastric outlet obstruction

Group Type: EXPERIMENTAL

Cook Magnetic Anastomosis Device (MAD) with Stent

Intervention Type: DEVICE

Gastro-jejunal anastomosis

Interventions

Cook Magnetic Anastomosis Device (MAD) with Stent

Gastro-jejunal anastomosis

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MED Institute, Incorporated

INDUSTRY

Sponsor Role: collaborator

Cook Endoscopy

INDUSTRY

Sponsor Role: collaborator

Cook Group Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Fockens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam Academic Medical Center

Locations

Hospital de Erasme

Brussels, , Belgium

Instituto di Clinical Chirurgica

Rome, , Italy

Amsterdam Academic Medical Center

Amsterdam, , Netherlands

University Medical Center Utrecht

Utrecht, , Netherlands

Countries

Belgium; Italy; Netherlands

Other Identifiers

900000

Identifier Type: -

Identifier Source: secondary_id

06-014

Identifier Type: -

Identifier Source: org_study_id