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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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