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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00991614




Registration number
NCT00991614
Ethics application status
Date submitted
13/08/2009
Date registered
8/10/2009
Date last updated
29/03/2012

Titles & IDs
Public title
EVOLUTION® Duodenal Stent for Duodenal or Gastric Outlet Obstruction Caused by Malignant Neoplasms
Scientific title
Treatment of Duodenal or Gastric Outlet Obstruction and Duodenal Strictures Caused by Malignant Neoplasms With the EVOLUTION® Duodenal Stent
Secondary ID [1] 0 0
09-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Duodenal Obstruction 0 0
Gastric Outlet Obstruction 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - EVOLUTION® Duodenal Stent

EVOLUTION® Duodenal Stent -


Treatment: Devices: EVOLUTION® Duodenal Stent
EVOLUTION® Duodenal Stent
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patency of the stent
Timepoint [1] 0 0
14 days
Secondary outcome [1] 0 0
Procedural success, implant duration, symptom resolution
Timepoint [1] 0 0
up to 6 months

Eligibility
Key inclusion criteria
* Patients for whom this device would be chosen in standard practice
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients for whom this device would not normally be chosen in standard practice

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2012
Sample size
Target
Accrual to date
Final
110
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Quebec
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Praha
Country [3] 0 0
Italy
State/province [3] 0 0
Milan
Country [4] 0 0
Italy
State/province [4] 0 0
Rome
Country [5] 0 0
Netherlands
State/province [5] 0 0
Rotterdam

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cook Group Incorporated
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00991614
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Professor Guido Costamagna, MD
Address 0 0
U.O. Endoscopia Digestiva Chirurgica
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00991614