Trial Information
Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System
Inclusion Criteria
Inclusion: per the IFU,
- colonic strictures caused by malignant neoplasms, and
- large bowel obstruction due to malignant strictures prior to colectomy.
Exclusion:
- central ischemia,
- any contraindication to GI endoscopy and any procedure to be performed in conjunction
with stent placement,
- suspected or impending perforation,
- intra-abdominal abscess/perforation,
- inability to pass wire guide or stent deployment system through the obstructed area,
- patients for whom endoscopic or percutaneous procedures are contraindicated,
- benign disease, and
- coagulopathy.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Relief of obstruction
Outcome Time Frame:
At the Conclusion of the Procedure
Safety Issue:
Yes
Authority:
Italy: Ministry of Health
Study ID:
09-022
NCT ID:
NCT01102283
Start Date:
April 2010
Completion Date:
February 2012
Related Keywords:
- Colonic Obstruction
- Colonic Stricture
- Large Bowel Obstruction
- Colonic obstruction
- Intestinal Obstruction
- Constriction, Pathologic