Clinical trial · Interventional
X-MAS Biliary Study With Covered Biliary Stent
A Non-Randomized, Multi-Center, Prospective, Single Arm Clinical Study of the X-SUIT NIR® Covered Biliary Metallic Stent for Palliation of Malignant Strictures in the Biliary Tree Via Endoscopic Approach
NCT01899976CI-TRIAL-00057783completedN/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 purpose of this study is to provide safety and efficacy data for the X-Suit NIR® Covered Biliary Metallic Stent for subjects with malignant stricture(s) in the biliary tree. The study is designed to support the regulatory requirement of a 510(k) marketing application in the United States.
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 Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| X-Suit NIR Covered Biliary Stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- X-Suit NIR Covered Biliary Stent
- description
- Stent implantation in the biliary tree
- interventionNames
- Device: X-Suit NIR Covered Biliary Stent
Primary outcomes (1)
- measure
- Maintenance of a total serum bilirubin level ≤ 3.0 mg/dL or a reduction of >30% if baseline value was greater than 3.0 mg/dL
- timeFrame
- 6 months follow up or prior to death, whichever comes first
- description
- Maintenance of a total serum bilirubin level ≤ 3.0 mg/dL or a reduction of \>30% if baseline value was greater than 3.0 mg/dL- outcome
Secondary outcomes (1)
- measure
- total number of adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 or older. 2. Clinical symptoms of biliary obstruction. 3. Presence of inoperable extrahepatic distal biliary obstruction by any malignant process (the subject not being a surgical candidate based on the finding of a pancreatic mass \>2.0cm or a severe medical illness). 4. Subject is willing and able to comply with the study procedures and provide written informed consent to participate in the study. 5. Insured by Social Security (applicable to subjects screened in France). Exclusion Criteria: * 1\. Participation in an Investigational Study within 90 days prior to date of subject consent. 2\. Perforation of any duct within the biliary tree. 3. Presence of more than one previously implanted plastic stent. 4. Previous plastic stent implantation less than 2 weeks prior to current procedure. 5\. Presence of a metal biliary stent. 6. Presence of any esophageal or duodenal stent. 7. Previous Bilroth II or Roux-en-Y gastric resection, a significant duodenal obstruction or any other altered anatomy which could prevent access to ampulla. 8\. Subjects for whom endoscopic procedures are contraindicated. 9. Subjects with known sensitivity to any components of the stent or delivery system. 10\. Subjects with active hepatitis or other hepatic diseases that may cause jaundice. 11\. Subjects with a WHO performance score of 4 - Bedbound (completely disabled, cannot carry on any self-care, totally confined to bed or chair). 12\. Subjects known to be pregnant. Cholangiographic exclusion criterion: 13\. Strictures that cannot be passed by the guide wire or the delivery system.
References
Publications (0)
Data not yet available
No reference posted for this study.