X-MAS Biliary Study With Covered Biliary Stent

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a non-randomized, multi-center, prospective, single arm clinical study of the X-Suit NIR® Covered Biliary Metallic Stent for the palliation of malignant strictures in the biliary tree via endoscopic approach. Adult males and females (≥ 18 years old), with clinical symptoms of biliary obstruction and inoperable extrahepatic biliary obstruction by any malignant process. The expected duration of this study is approximately 18 months from the time of first subject enrollment to the time of the last subject's 6-month post stent implantation follow-up visit.

Official Title
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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

Conditions
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Biliary Tract Cancer

Intervention / Treatment
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* Device: X-Suit NIR Covered Biliary Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older. Clinical symptoms of biliary obstruction. 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). Subject is willing and able to comply with the study procedures and provide written informed consent to participate in the study. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: X-Suit NIR Covered Biliary Stent<br>Stent implantation in the biliary tree | Device: X-Suit NIR Covered Biliary Stent<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 6 months follow up or prior to death, whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total number of adverse events | total number of adverse events (anticipated and unanticipated) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covered biliary stent, X-Suit NIR Covered Biliary Stent, malignant strictures in biliary tree