Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System

Cook Group

Status: Completed

Conditions: Colonic Stricture; Colonic Obstruction; Large Bowel Obstruction

Treatments: Device: Evolution(R) Colonic Stent

Study type: Observational

Funder types: Industry

Identifiers

NCT01102283

100041 (Other Identifier)

09-022

Details and patient eligibility

About

The objective of this registry is to compile clinical data on the use of the Evolution® Colonic Stent System for the palliative treatment of colonic obstruction or strictures caused by malignant neoplasms and to relieve acute large bowel obstruction prior to colectomy in patients with malignant strictures.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

80 participants in 1 patient group

Stent Group

Treatment:

Device: Evolution(R) Colonic Stent