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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00487552
Recruitment Status : Terminated (Failure to achieve one of the primary endpoints.)
First Posted : June 18, 2007
Results First Posted : July 27, 2012
Last Update Posted : August 23, 2017
Sponsor:
Collaborators:
MED Institute, Incorporated
Cook Endoscopy
Information provided by (Responsible Party):
Cook Group Incorporated

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Outlet Obstruction Device: Cook Magnetic Anastomosis Device (MAD) with Stent Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : April 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
palliative treatment of gastric outlet obstruction
 Device: Cook Magnetic Anastomosis Device (MAD) with Stent
Gastro-jejunal anastomosis


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487552


Locations
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Belgium
Hospital de Erasme
Brussels, Belgium
Italy
Instituto di Clinical Chirurgica
Rome, Italy
Netherlands
Amsterdam Academic Medical Center
Amsterdam, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
Cook Group Incorporated
MED Institute, Incorporated
Cook Endoscopy
Investigators
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Principal Investigator: Paul Fockens, MD, PhD Amsterdam Academic Medical Center
More Information
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Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT00487552    
Other Study ID Numbers: 06-014
900000
First Posted: June 18, 2007    Key Record Dates
Results First Posted: July 27, 2012
Last Update Posted: August 23, 2017
Last Verified: July 2017
Keywords provided by Cook Group Incorporated:
endoscopy
esophagogastroduodenoscopy
gastric outlet obstruction
gastro-jejunostomy
 gastric malignancy
duodenal stent
Malignant Gastric Outlet Obstruction
Additional relevant MeSH terms:
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Gastric Outlet Obstruction
Pyloric Stenosis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases