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

NCT ID: NCT00991614

Last Updated: 2012-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-03-31

Brief Summary

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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

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Conditions

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Duodenal Obstruction Gastric Outlet Obstruction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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EVOLUTION® Duodenal Stent

EVOLUTION® Duodenal Stent

Intervention Type DEVICE

EVOLUTION® Duodenal Stent

Interventions

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EVOLUTION® Duodenal Stent

EVOLUTION® Duodenal Stent

Intervention Type DEVICE

Other Intervention Names

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TC325

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Professor Guido Costamagna, MD

Role: PRINCIPAL_INVESTIGATOR

U.O. Endoscopia Digestiva Chirurgica

Locations

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Westmead Hospital

Sydney, , Australia

Site Status

Hopital Saint-Luc / CHUM

Montreal, Quebec, Canada

Site Status

Institution for Clinical and Experimental Medicine

Prague, , Czechia

Site Status

IRCCS Instituto Clinico Humanitas

Milan, , Italy

Site Status

U.O. Endoscopia Digestiva Chirurgica

Rome, , Italy

Site Status

Erasmus MC University Medical Center

Rotterdam, , Netherlands

Site Status

Countries

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Australia Canada Czechia Italy Netherlands

References

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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.

Reference Type DERIVED
PMID: 23932009 (View on PubMed)

Other Identifiers

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09-005

Identifier Type: -

Identifier Source: org_study_id

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