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

This study has been terminated.
(Failure to achieve one of the primary endpoints.)
MED Institute, Incorporated
Cook Endoscopy
Information provided by (Responsible Party):
Cook Identifier:
First received: June 15, 2007
Last updated: December 29, 2015
Last verified: June 2012
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.

Condition Intervention Phase
Gastric Outlet Obstruction Device: Cook Magnetic Anastomosis Device (MAD) with Stent Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Endoscopic Gastroenteric Anastomosis Formed by Magnetic Compression and Stent Placement for Palliation of Malignant Gastric Outlet Obstruction

Resource links provided by NLM:

Further study details as provided by Cook:

Primary Outcome Measures:
  • Success Rate Associated With the Creation of a Gastro-jejunal Anastomosis Using the Cook Magnetic Anastomosis Device With Trans-anastomotic Deployment of a Gastro-jejunal or Duodenal Stent [ Time Frame: Approximately 8-10 days ]
    Success is defined as placement of the gastric and jejunal magnets, creation of the anastomosis, and deployment of the gastro-jejunal stent.

Enrollment: 18
Study Start Date: January 2008
Study Completion Date: April 2011
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
palliative treatment of gastric outlet obstruction
Device: Cook Magnetic Anastomosis Device (MAD) with Stent
Gastro-jejunal anastomosis

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00487552

Hospital de Erasme
Brussels, Belgium
Instituto di Clinical Chirurgica
Rome, Italy
Amsterdam Academic Medical Center
Amsterdam, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
MED Institute, Incorporated
Cook Endoscopy
Principal Investigator: Paul Fockens, MD, PhD Amsterdam Academic Medical Center
  More Information

Responsible Party: Cook Identifier: NCT00487552     History of Changes
Other Study ID Numbers: 06-014
Study First Received: June 15, 2007
Results First Received: January 16, 2012
Last Updated: December 29, 2015

Keywords provided by Cook:
gastric outlet obstruction
gastric malignancy
duodenal stent
Malignant Gastric Outlet Obstruction

Additional relevant MeSH terms:
Gastric Outlet Obstruction
Pyloric Stenosis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on June 23, 2017