Status:
COMPLETED
X-MAS Biliary Study With Covered Biliary Stent
Lead Sponsor:
Medinol Ltd.
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed 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 endo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2017
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01899976
Start Date
August 1 2013
End Date
November 13 2017
Last Update
April 13 2022
Active Locations (9)
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1
Hôpital Erasme Brussels (ULB)
Brussels, Belgium, 1070
2
Hillel Yafeh Medical Center
Hadera, Israel, 38100
3
Rambam Medical Center
Haifa, Israel, 31096
4
Shaare Zedek Medical Center
Jerusalem, Israel, 91031