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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00991614
First received: August 13, 2009
Last updated: March 28, 2012
Last verified: March 2012

August 13, 2009
March 28, 2012
December 2009
June 2011   (final data collection date for primary outcome measure)
Patency of the stent [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Patency [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00991614 on ClinicalTrials.gov Archive Site
Procedural success, implant duration, symptom resolution [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
EVOLUTION® Duodenal Stent for Duodenal or Gastric Outlet Obstruction Caused by Malignant Neoplasms
Treatment of Duodenal or Gastric Outlet Obstruction and Duodenal Strictures Caused by Malignant Neoplasms With the EVOLUTION® Duodenal Stent

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Duodenal Obstruction
  • Gastric Outlet Obstruction
Device: EVOLUTION® Duodenal Stent
EVOLUTION® Duodenal Stent
Other Name: TC325
EVOLUTION® Duodenal Stent
Intervention: Device: EVOLUTION® Duodenal Stent
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
March 2012
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Czech Republic,   Italy,   Netherlands
 
NCT00991614
09-005
No
Cook
Cook
Not Provided
Principal Investigator: Professor Guido Costamagna, MD U.O. Endoscopia Digestiva Chirurgica
Cook
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP