Brief Title
X-MAS Biliary Study With Covered Biliary Stent
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
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 to support the regulatory requirement of a 510(k) marketing application in
the United States.
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 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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
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
Secondary Outcome
Safety
Condition
Biliary Tract Cancer
Intervention
X-Suit NIR Covered Biliary Stent
Study Arms / Comparison Groups
X-Suit NIR Covered Biliary Stent
Description: Stent implantation in the biliary tree
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
68
Start Date
August 2013
Completion Date
December 2016
Primary Completion Date
December 2016
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT01899976
Organization ID
Protocol Number BI-03-01
Responsible Party
Sponsor
Study Sponsor
Medinol Ltd.
Study Sponsor
, ,
Verification Date
January 2016