Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction - Full Text View

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