NCT01102283

Completed

Treatment of Colonic Obstruction With Cook Evolution® Coloni...

Cook Group Incorporated Source

Compare

Other study identifiers

Sponsor study identifier

09-022

Secondary identifiers

100041

OTHER · Cook

Study Type

observational

Actual enrollment (reported)

80

Locations

7 countries

Sites

10

Timeline

Study Start

April 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2011

Actual (reported)

Study Completion

February 2012

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 80 participants
Study completion date: February 2012
Actual (reported)
Listed locations: 7 countries · 10 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 29, 2010
Actual (reported)
Study Start
April 2010
Date type not reported
This date has not been verified as actual or estimated.
First Posted
April 13, 2010
Actual (reported)
Primary Completion
July 2011
Actual (reported)
Study Completion
February 2012
Actual (reported)

Last Updated: September 18, 2013
Status Verified: September 2013
Last Update Submitted: September 16, 2013

Conditions

Colonic Obstruction Colonic Stricture Large Bowel Obstruction

Keywords

Colonic obstruction

Outcome Measures

Primary Outcomes (1)

Relief of obstruction
At the Conclusion of the Procedure

Secondary Outcomes (3)

Implant Duration
6 months
Symptoms at Follow-up
6 months
Complications
6 months

Study Arms (1)

Stent Group

Device: Evolution(R) Colonic Stent

Interventions

Evolution(R) Colonic StentDevice

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.

Stent Group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Referral Centers

You may qualify if:

colonic strictures caused by malignant neoplasms, and

Sponsors & Collaborators

Cook Group Incorporated
Industrylead

Study Sites (10)

Kingston General Hospital

Kingston, Ontario, K7L5G2, Canada

St. Michael's Hospital

Toronto, Ontario, M5B1N8, Canada

Odense Universitetshospital

Odense, 5000, Denmark

Institut Paoli Calmettes

Marseille, 13009, France

Instituto Clinico Humanitas IRCCS

Milan, 20089, Italy

Deventer Ziekenhuis

Deventer, 7416 SE, Netherlands

Hospital de Basurto

Bilbao, Bilbao, 48013, Spain

Enrollment

80 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 29, 2010

First Posted

April 13, 2010

Study Start

April 2010

Date type not reported

This date has not been verified as actual or estimated.

large bowel obstruction due to malignant strictures prior to colectomy.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Hospital Universitari de Girona

Girona, 17007, Spain

Hospital Son Llatzer

Palma de Mallorca, 48013, Spain

University College of London Hospital

London, NW 1 2BU, United Kingdom

Primary Completion

July 2011

Actual (reported)

Study Completion

February 2012

Actual (reported)

Last Updated

September 18, 2013

Record last verified: 2013-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01102283
Data provider: ClinicalTrials.gov
Source updated: 2013-09-18
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:06 UTC

Locations

CA(2)DK(1)ES(3)FR(1)GB(1)IT(1)NL(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Stent Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations