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

This study has been terminated.
(Failure to achieve one of the primary endpoints.)
Sponsor:
Collaborators:
MED Institute, Incorporated
Cook Endoscopy
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00487552
First received: June 15, 2007
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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: Allocation: Non-Randomized
Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
MED Institute, Incorporated
Cook Endoscopy
Investigators
Principal Investigator: Paul Fockens, MD, PhD Amsterdam Academic Medical Center
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00487552     History of Changes
Other Study ID Numbers: 06-014, 900000
Study First Received: June 15, 2007
Results First Received: January 16, 2012
Last Updated: June 21, 2012
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

Additional relevant MeSH terms:
Gastric Outlet Obstruction
Pyloric Stenosis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 16, 2014