- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01899976
X-MAS Biliary Study With Covered Biliary Stent
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Brussels, Belgium, 1070
- Hôpital Erasme Brussels (ULB)
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Hadera, Israel, 38100
- Hillel Yafeh Medical Center
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Haifa, Israel, 31096
- Rambam Medical Center
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Jerusalem, Israel, 91031
- Shaare Zedek Medical Center
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Jerusalem, Israel, 91120
- Haddasah Medical Center
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Ramat Gan, Israel, 52621
- Sheba Medical Center, Tel Hashomer
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Tel Aviv, Israel, 64239
- Tel Aviv Sourasky Medical Center
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Amsterdam, Netherlands, 1105 AZ
- Academic Medical Center (AMC)
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Heidelberglaan
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Utrecht, Heidelberglaan, Netherlands, 100, 3584 CX
- University Medical Center Utrecht
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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OTHER: X-Suit NIR Covered Biliary Stent
Stent implantation in the biliary tree
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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
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6 months follow up or prior to death, whichever comes first
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total number of adverse events
Time Frame: 6 months
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total number of adverse events (anticipated and unanticipated)
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter D Siersema, Prof., University Medical Center Utrecht, Netherlands
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protocol Number BI-03-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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