Clinical trial · Interventional
Evolution® Biliary Stent System-Fully Covered
Evaluation for the Effectiveness of Evolution® Biliary Stent System-Fully Covered
NCT02104076CI-TRIAL-00028492completedN/AClinicalTrials.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-Fully Covered study is a clinical trial approved by the US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered when used in palliation of malignant neoplasms in the biliary tree.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinomas/Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Evolution® Biliary Stent-Fully Covered | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Evolution® Biliary Stent-Fully Covered
- interventionNames
- Device: Evolution® Biliary Stent-Fully Covered
Primary outcomes (2)
- measure
- Percentage of patients free from symptomatic recurrent of biliary obstruction requiring reintervention
- timeFrame
- 6 months
- measure
- Total Serum Bilirubin ≤ 3.0 mg/dL
- timeFrame
- 1 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Inoperable malignant neoplasm causing biliary obstruction or stricture that requires a fully covered metal stent Exclusion Criteria: * \< 18 years of age * Unwilling or unable to sign and date the informed consent * Unwilling or unable to comply with the follow-up schedule * Undergone or is planning to undergo brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources * Participating in another investigational drug or device study in which patient has not completed the follow-up phase for the primary endpoint at least 30 days prior to enrollment * Endoscopic procedures are contraindicated * Current anatomy upstream of intended stent placement compromising the flow of bile from the liver such that stent placement may not alleviate the biliary obstruction symptoms * Presence of a metal biliary stent * Presence of an esophageal or duodenal stent * Hypersensitivity/allergy or contraindication to any component of the stent, delivery system, or medication required to complete the procedure,which in the investigator's opinion cannot be adequately premedicated * Coagulopathy * Diffuse intrahepatic metastases that involves \> 10 % of the liver * Life expectancy of \< 3 months * Pregnant * Active alcohol or substance abuse issue * Jaundice secondary to a cause other than biliary duct obstruction * Additional endoscopic restrictions as specified in the Clinical Investigation Plan
References
Publications (0)
Data not yet available
No reference posted for this study.