Treatment of Colonic Obstruction With Cook Evolution® Col... | NCT01102283

Studies
Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System

NCT01102283

Sponsor

Cook Group Incorporated

Status

Completed

Last Update Posted

Sep 18, 2013Estimated

Enrollment

80Actual

Phase

Not provided

Conditions

Colonic Obstruction
Colonic Stricture
Large Bowel Obstruction

Interventions

Evolution(R) Colonic Stent

Countries

Canada
Denmark
France
Italy
Netherlands
Spain
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
100041	Other Identifier	Cook

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Jul 2011Actual

Completion Date

Feb 2012Actual

First Submitted Date

Mar 29, 2010

First Submission Date that Met QC Criteria

Apr 12, 2010

First Posted Date

Apr 13, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2013

Last Update Posted Date

Sep 18, 2013Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stent Group			Device: Evolution(R) Colonic Stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Evolution(R) Colonic Stent	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relief of obstruction		At the Conclusion of the Procedure

Secondary Outcomes

Measure	Description	Time Frame
Implant Duration		6 months
Symptoms at Follow-up		6 months
Complications

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Referral Centers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kingston General Hospital		Kingston	Ontario	K7L5G2	Canada
St. Michael's Hospital