An observational study in Biliary Tract Neoplasms, Neoplasms and Gastrointestinal Diseases, sponsored by Cook Group Incorporated. Completed at 9 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-08.
Sponsored by Cook Group Incorporated · Observational
The Evolution® Biliary Stent System Clinical Study is a clinical trial on a commercially available device to gather physician experience with the Cook Evolution® Biliary Stent System for the palliation of cancer in the biliary tree. Patients will be treated as per usual medical practices.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 113 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Cook Group Incorporated is the lead sponsor of 73 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Candidates for biliary stent placement based on institutional guidelines and product IFU.
Exclusion Criteria:
Device: Evolution® Biliary Stent - Uncovered
Commercially available device
Freedom from symptomatic recurrent biliary obstruction requiring reintervention
Time frame: 6 months
Technical success
Technical success is defined as a stent successfully delivered and placed at its intended location at the end of the procedure.
Time frame: Immediately following completion of the stent placement procedure
Incidence of device-related adverse events
Time frame: 6 months
Ease of use
Ease of use will be evaluated on a five point scale ranging from very easy to very difficult.
Time frame: Immediately following completion of the stent placement procedure
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Cook Group Incorporated