Clinical trial · Interventional
Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction
Endoscopic Gastroenteric Anastomosis Formed by Magnetic Compression and Stent Placement for Palliation of Malignant Gastric Outlet Obstruction
NCT00487552CI-TRIAL-00029230MADterminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Failure to achieve one of the primary endpoints.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Outlet Obstruction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cook Magnetic Anastomosis Device (MAD) with Stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- palliative treatment of gastric outlet obstruction
- interventionNames
- Device: Cook Magnetic Anastomosis Device (MAD) with Stent
Primary outcomes (1)
- measure
- 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
- description
- Success is defined as placement of the gastric and jejunal magnets, creation of the anastomosis, and deployment of the gastro-jejunal stent.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.