Clinical trial · Interventional
Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
NCT00713427CI-TRIAL-00052981completedN/AResults postedClinicalTrials.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)
This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary Partially Covered Stent as a Palliative treatment for malignant bile duct obstruction.
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 |
|---|---|---|---|
| Biliary Strictures Caused by Malignant Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| WallFlex™ Biliary Partially-Covered Stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- WallFlex Stent
- description
- All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.
- interventionNames
- Device: WallFlex™ Biliary Partially-Covered Stent
Primary outcomes (1)
- measure
- Number of Participants With Absence of Recurrent Biliary Obstruction
- timeFrame
- Up to 6 months post treatment or prior to death, whichever came first
- description
- Defined as absence of recurrent biliary obstruction defined as absence of biliary symptoms. Biliary symptoms, included, but were not limited to jaundice, itching, right upper quadrant abdominal pain, nausea, vomiting, fever, and dark urine. Symptom assessment occurred during the Screening/Baseline period and at all follow-up time points.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * Inoperable extrahepatic biliary obstruction by any malignant process * Indicated for metal stent placement for palliative treatment of biliary stricture(s) produced by malignant neoplasms * Willing and able to comply with the study procedures and provide written informed consent to participate in the study Exclusion Criteria: * Participation in another invesitgational study within 90 days prior to date of patient consent. * Strictures that cannot be dialated enough to pass the delivery system * Perforation of any duct within the biliary tree * Presence of any esophageal or duodenal stent * Patients for whom endoscopic procedures are contraindicated * Patients with known senesitivity to any components of the stent or delivery system * Patients with active hepatitis
References
Publications (0)
Data not yet available
No reference posted for this study.