Biliary Tract, Biliary Tract Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Neoplasms, Stents
Conditions
Keywords
Biliary Tract Neoplasms, Neoplasms, Gastrointestinal Diseases, Digestive System Diseases, Biliary Tract, Stents
Brief summary
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.
Interventions
DEVICEEvolution® Biliary Stent - Uncovered
Commercially available device
Sponsors
Cook Group Incorporated
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is considered a candidate for stent placement based on institutional guidelines and product IFU.
Exclusion criteria
* Patient is less than 18 years of age. * Patient is unable or unwilling to provide written informed consent. * Patient is unable or unwilling to comply with the follow-up schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from symptomatic recurrent biliary obstruction requiring reintervention | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | Immediately following completion of the stent placement procedure | Technical success is defined as a stent successfully delivered and placed at its intended location at the end of the procedure. |
| Incidence of device-related adverse events | 6 months | — |
| Ease of use | Immediately following completion of the stent placement procedure | Ease of use will be evaluated on a five point scale ranging from very easy to very difficult. |
Countries
Canada, United States
Outcome results
None listed