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

Primary Purpose

Gastric Outlet Obstruction

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cook Magnetic Anastomosis Device (MAD) with Stent
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastric Outlet Obstruction focused on measuring endoscopy, esophagogastroduodenoscopy, gastric outlet obstruction, gastro-jejunostomy, gastric malignancy, duodenal stent, Malignant Gastric Outlet Obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Erasme
  • Instituto di Clinical Chirurgica
  • Amsterdam Academic Medical Center
  • University Medical Center Utrecht

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

palliative treatment of gastric outlet obstruction

Outcomes

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
Success is defined as placement of the gastric and jejunal magnets, creation of the anastomosis, and deployment of the gastro-jejunal stent.

Secondary Outcome Measures

Full Information

First Posted
June 15, 2007
Last Updated
July 20, 2017
Sponsor
Cook Group Incorporated
Collaborators
MED Institute, Incorporated, Cook Endoscopy
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1. Study Identification

Unique Protocol Identification Number
NCT00487552
Brief Title
Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction
Acronym
MAD
Official Title
Endoscopic Gastroenteric Anastomosis Formed by Magnetic Compression and Stent Placement for Palliation of Malignant Gastric Outlet Obstruction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Failure to achieve one of the primary endpoints.
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated
Collaborators
MED Institute, Incorporated, Cook Endoscopy

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Outlet Obstruction
Keywords
endoscopy, esophagogastroduodenoscopy, gastric outlet obstruction, gastro-jejunostomy, gastric malignancy, duodenal stent, Malignant Gastric Outlet Obstruction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
palliative treatment of gastric outlet obstruction
Intervention Type
Device
Intervention Name(s)
Cook Magnetic Anastomosis Device (MAD) with Stent
Intervention Description
Gastro-jejunal anastomosis
Primary Outcome Measure Information:
Title
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
Description
Success is defined as placement of the gastric and jejunal magnets, creation of the anastomosis, and deployment of the gastro-jejunal stent.
Time Frame
Approximately 8-10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Fockens, MD, PhD
Organizational Affiliation
Amsterdam Academic Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Erasme
City
Brussels
Country
Belgium
Facility Name
Instituto di Clinical Chirurgica
City
Rome
Country
Italy
Facility Name
Amsterdam Academic Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
University Medical Center Utrecht
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction

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