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

This study is currently recruiting participants.
Verified by Cook, December 2008

Sponsors and Collaborators: Cook
MED Institute, Incorporated
Cook Endoscopy
Information provided by: Cook
ClinicalTrials.gov Identifier: NCT00487552
  Purpose

The purpose of this study is to determine in 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
Phase I

MedlinePlus related topics:   Endoscopy   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:   Endoscopic Gastroenteric Anastomosis Formed by Magnetic Compression and Stent Placement for Palliation of Malignant Gastric Outlet Obstruction

Further study details as provided by Cook:

Primary Outcome Measures:
  • Success rate and safety associated with the creation of a gastro-jejunal anastomosis using the Cook Magnetic Anastomosis Device with trans-anastomotic deployment of the Yo-Yo gastro-jejunal stent [ Time Frame: 8-10 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment:   40
Study Start Date:   January 2008
Estimated Study Completion Date:   January 2010
Estimated Primary Completion Date:   January 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
palliative treatment of gastric outlet obstruction
Device: Cook Magnetic Anastomosis Device
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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patients with unresectable malignant 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487552

Contacts
Contact: David R Wagner, MS     765-463-7537     wagner@medinst.com    

Locations
Belgium
Hospital de Erasme     Recruiting
      Brussels, Belgium
      Contact: Jacques Deviere, MD, PhD            
France, Cedex
Institut Paoli-Calmettes     Not yet recruiting
      Marseille, Cedex, France, 13273
      Contact: Marc Giovannini     +33 4 91 22 35 68     giovanninim@marseille.fnclcc.fr    
Italy
Instituto di Clinical Chirurgica     Recruiting
      Rome, Italy
      Contact: Guido Costamagna, MD, PhD     06 3551 1515        
Netherlands
Amsterdam Academic Medical Center     Recruiting
      Amsterdam, Netherlands
      Contact: Paul Fockens, MD, PhD     +31 20 556 3534        
University Medical Center Utrecht     Recruiting
      Utrecht, Netherlands
      Contact: Peter Siersema, MD, PhD     +31 30 250 6274        

Sponsors and Collaborators
Cook
MED Institute, Incorporated
Cook Endoscopy

Investigators
Principal Investigator:     Paul Fockens, MD, PhD     Amsterdam Academic Medical Center    
  More Information


Responsible Party:   Cook Endoscopy ( Marge Walls-Walker, Regulatory Affairs Specialist )
Study ID Numbers:   06-014, 900000
First Received:   June 15, 2007
Last Updated:   December 1, 2008
ClinicalTrials.gov Identifier:   NCT00487552
Health Authority:   Netherlands: Medical Ethics Review Committee (METC);   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO);   Belgium: Institutional Review Board;   Italy: Ethics Committee

Keywords provided by Cook:
endoscopy  
esophagogastroduodenoscopy  
gastric outlet obstruction  
gastro-jejunostomy  
gastric malignancy
duodenal stent
Malignant Gastric Outlet Obstruction

Study placed in the following topic categories:
Digestive System Diseases
Stomach Diseases
Gastrointestinal Diseases
Stomach Neoplasms
Stomach cancer
Gastric Outlet Obstruction

ClinicalTrials.gov processed this record on December 03, 2008




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