EVOLUTION® Duodenal Stent for Duodenal or Gastric Outlet... | NCT00991614

Studies
EVOLUTION® Duodenal Stent for Duodenal or Gastric Outlet Obstruction Caused by Malignant Neoplasms

NCT00991614

Sponsor

Cook Group Incorporated

Status

Completed

Last Update Posted

Mar 29, 2012Estimated

Enrollment

110Actual

Phase

Not provided

Conditions

Duodenal Obstruction
Gastric Outlet Obstruction

Interventions

EVOLUTION® Duodenal Stent

Countries

Australia
Canada
Czechia
Italy
Netherlands

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

Status Module

Record Verification Date

Mar 2012

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

Dec 2009

Primary Completion Date

Jun 2011Actual

Completion Date

Mar 2012Actual

First Submitted Date

Aug 13, 2009

First Submission Date that Met QC Criteria

Oct 7, 2009

First Posted Date

Oct 8, 2009Estimated

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

Mar 28, 2012

Last Update Posted Date

Mar 29, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this investigation is to compile clinical experience on the use of the Evolution® Duodenal Stent (Cook Ireland), a CE marked device intended for the palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms. It is not the goal to change the usual treatment practice of the investigator or the center, nor to collect information on uses outside the product's indications. Patients will be treated as per usual medical practices.

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

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EVOLUTION® Duodenal Stent			Device: EVOLUTION® Duodenal Stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EVOLUTION® Duodenal Stent	Device	EVOLUTION® Duodenal Stent	EVOLUTION® Duodenal Stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patency of the stent		14 days

Secondary Outcomes

Measure	Description	Time Frame
Procedural success, implant duration, symptom resolution		up to 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients for whom this device would be chosen in standard practice

Exclusion Criteria:

Patients for whom this device would not normally be chosen in standard practice

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

Patients who are referred into regional specialty centers for treatment of GI malignancy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Professor Guido Costamagna, MD	U.O. Endoscopia Digestiva Chirurgica	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Westmead Hospital		Sydney		2145	Australia
Hopital Saint-Luc / CHUM

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23932009	Derived	Tringali A, Didden P, Repici A, Spaander M, Bourke MJ, Williams SJ, Spicak J, Drastich P, Mutignani M, Perri V, Roy A, Johnston K, Costamagna G. Endoscopic treatment of malignant gastric and duodenal strictures: a prospective, multicenter study. Gastrointest Endosc. 2014 Jan;79(1):66-75. doi: 10.1016/j.gie.2013.06.032. Epub 2013 Aug 6.

ID	Term
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D004380	Duodenal Obstruction
D017219	Gastric Outlet Obstruction