Clinical trial · Observational
Evolution® Biliary Stent System Clinical Study
Palliation of Biliary Neoplasms With the Cook Evolution® Biliary Stent System
NCT01962168CI-TRIAL-00017425completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract | — | UNRESOLVED | — |
| Biliary Tract Neoplasms | — | UNRESOLVED | — |
| Digestive System Diseases | — | UNRESOLVED | — |
| Gastrointestinal Diseases | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Stents | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Evolution® Biliary Stent - Uncovered | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Evolution® Biliary Stent - Uncovered
- interventionNames
- Device: Evolution® Biliary Stent - Uncovered
Primary outcomes (1)
- measure
- Freedom from symptomatic recurrent biliary obstruction requiring reintervention
- timeFrame
- 6 months
Secondary outcomes (3)
- measure
- Technical success
- timeFrame
- Immediately following completion of the stent placement procedure
- description
- Technical success is defined as a stent successfully delivered and placed at its intended location at the end of the procedure.
- measure
- Incidence of device-related adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLawrence C, Nieto J, Parsons WG, Roy A, Guda NM, Steinberg SE, Hasan MK, Bucobo JC, Nagula S, Dey ND, Buscaglia JM; Study Investigators. A newly designed uncovered biliary stent for palliation of malignant obstruction: results of a prospective study. BMC Gastroenterol. 2020 Jun 10;20(1):184. doi: 10.1186/s12876-020-01325-9. PMID 32522161