TerminatedNot Applicable

Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction

Stopped: Failure to achieve one of the primary endpoints.

Belgium, Italy, Netherlands18 participantsStarted 2008-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Approximately 8-10 days

Trial details

NCT IDNCT00487552

SponsorCook Group Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-01

Results submitted2012-01-16

View on ClinicalTrials.gov More Gastric Outlet Obstruction trials