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

July 20, 2017 updated by: Cook Group Incorporated

Endoscopic Gastroenteric Anastomosis Formed by Magnetic Compression and Stent Placement for Palliation of Malignant Gastric Outlet Obstruction

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Hospital de Erasme
  • Italy
      • Rome, Italy
        • Instituto di Clinical Chirurgica
  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam Academic Medical Center
      • Utrecht, Netherlands
        • University Medical Center Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 8-10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Collaborators

MED Institute, Incorporated
Cook Endoscopy

Investigators

  • Principal Investigator: Paul Fockens, MD, PhD, Amsterdam Academic Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

June 15, 2007

First Submitted That Met QC Criteria

June 15, 2007

First Posted (Estimate)

June 18, 2007

Study Record Updates

Last Update Posted (Actual)

August 23, 2017

Last Update Submitted That Met QC Criteria

July 20, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-014
  • 900000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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