Overview

This trial is active, not recruiting.

Condition biliary tract cancer
Treatment x-suit nir covered biliary stent
Phase phase 3
Sponsor Medinol Ltd.
Start date August 2013
End date December 2016
Trial size 68 participants
Trial identifier NCT01899976, Protocol Number BI-03-01

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Stent implantation in the biliary tree
x-suit nir covered biliary stent

Primary Outcomes

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
time frame: 6 months follow up or prior to death, whichever comes first

Secondary Outcomes

Measure
Safety
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Medinol Ltd..