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Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System


N/A
18 Years
N/A
Not Enrolling
Both
Colonic Obstruction, Colonic Stricture, Large Bowel Obstruction

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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

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