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

Sponsor:	Cook
Collaborators:	MED Institute, Incorporated Cook Endoscopy
Information provided by:	Cook
ClinicalTrials.gov Identifier:	NCT00487552

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	Phase I

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

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy

U.S. FDA Resources

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. [ Time Frame: 8-14 days ] [ Designated as safety issue: Yes ]
Trans-anastomotic deployment of a gastro-jejunal or duodenal stent. [ Time Frame: 10-14 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 2011
Estimated Primary Completion Date:	January 2011 (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 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
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

No publications provided

Responsible Party:	Cook Endoscopy ( Marge Walls-Walker, Regulatory Affairs Specialist )
Study ID Numbers:	06-014, 900000
Study First Received:	June 15, 2007
Last Updated:	July 13, 2009
ClinicalTrials.gov Identifier:	NCT00487552 History of Changes
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:

Digestive System Diseases
Stomach Diseases
Gastrointestinal Diseases
Gastric Outlet Obstruction

ClinicalTrials.gov processed this record on November 27, 2009