Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction

Gastric Outlet Obstruction Clinical Trial

— MAD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00487552
• Other study ID #: 06-014
• Secondary ID: 900000
• Status: Terminated
• Phase: Phase 1
• First received: June 15, 2007
• Last updated: December 29, 2015
• Start date: January 2008
• Est. completion date: April 2011

Study information

• Verified date: June 2012
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Belgium: Institutional Review BoardItaly: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: April 2011
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gastric Outlet Obstruction
• Pyloric Stenosis

Intervention

Device:
• Cook Magnetic Anastomosis Device (MAD) with Stent
Gastro-jejunal anastomosis

Locations

Country	Name	City	State
Belgium	Hospital de Erasme	Brussels
Italy	Instituto di Clinical Chirurgica	Rome
Netherlands	Amsterdam Academic Medical Center	Amsterdam
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
Cook	Cook Endoscopy, MED Institute, Incorporated

Countries where clinical trial is conducted

Belgium,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Approximately 8-10 days	Yes