Back to resultsX-MAS Biliary Study With Covered Biliary Stent
Primary Purpose
Biliary Tract Cancer
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
X-Suit NIR Covered Biliary Stent
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Tract Cancer focused on measuring covered biliary stent, X-Suit NIR Covered Biliary Stent, malignant strictures in biliary tree
Eligibility Criteria
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.
Sites / Locations
- Hôpital Erasme Brussels (ULB)
- Hillel Yafeh Medical Center
- Rambam Medical Center
- Shaare Zedek Medical Center
- Haddasah Medical Center
- Sheba Medical Center, Tel Hashomer
- Tel Aviv Sourasky Medical Center
- University Medical Center Utrecht
- Academic Medical Center (AMC)
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
X-Suit NIR Covered Biliary Stent
Arm Description
Stent implantation in the biliary tree
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
total number of adverse events
total number of adverse events (anticipated and unanticipated)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01899976
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
November 13, 2017 (Actual)
Study Completion Date
November 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medinol Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Cancer
Keywords
covered biliary stent, X-Suit NIR Covered Biliary Stent, malignant strictures in biliary tree
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
X-Suit NIR Covered Biliary Stent
Arm Type
Other
Arm Description
Stent implantation in the biliary tree
Intervention Type
Device
Intervention Name(s)
X-Suit NIR Covered Biliary Stent
Primary Outcome Measure Information:
Title
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
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
Time Frame
6 months follow up or prior to death, whichever comes first
Secondary Outcome Measure Information:
Title
total number of adverse events
Description
total number of adverse events (anticipated and unanticipated)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter D Siersema, Prof.
Organizational Affiliation
University Medical Center Utrecht, Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Erasme Brussels (ULB)
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Hillel Yafeh Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Haddasah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Sheba Medical Center, Tel Hashomer
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
University Medical Center Utrecht
City
Utrecht
State/Province
Heidelberglaan
ZIP/Postal Code
100, 3584 CX
Country
Netherlands
Facility Name
Academic Medical Center (AMC)
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
X-MAS Biliary Study With Covered Biliary Stent
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