Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System

Colonic Obstruction Clinical Trial

Official title:

Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102283
• Other study ID #: 09-022
• Secondary ID: 100041
• Status: Completed
• Phase: N/A
• First received: March 29, 2010
• Last updated: September 16, 2013
• Start date: April 2010
• Est. completion date: February 2012

Study information

• Verified date: September 2013
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonic Obstruction
• Colonic Stricture
• Intestinal Obstruction
• Large Bowel Obstruction

Intervention

Device:
• Evolution(R) Colonic Stent
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.

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Denmark	Odense Universitetshospital	Odense
France	Institut Paoli Calmettes	Marseille
Italy	Instituto Clinico Humanitas IRCCS	Milan
Netherlands	Deventer Ziekenhuis	Deventer
Spain	Hospital de Basurto	Bilbao
Spain	Hospital Universitari de Girona	Girona
Spain	Hospital Son Llatzer	Palma de Mallorca
United Kingdom	University College of London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Countries where clinical trial is conducted

Canada,  Denmark,  France,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief of obstruction		At the Conclusion of the Procedure	Yes
Secondary	Implant Duration		6 months	Yes
Secondary	Symptoms at Follow-up		6 months	Yes
Secondary	Complications	perforation, migration, obstruction, GI bleeding requiring intervention	6 months	Yes