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X-MAS Biliary Study With Covered Biliary Stent

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01899976
Recruitment Status : Unknown
Verified January 2016 by Medinol Ltd..
Recruitment status was:  Active, not recruiting
First Posted : July 16, 2013
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Medinol Ltd.

Tracking Information
First Submitted Date  ICMJE July 8, 2013
First Posted Date  ICMJE July 16, 2013
Last Update Posted Date January 20, 2016
Study Start Date  ICMJE August 2013
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2013)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01899976 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2013)
Safety [ Time Frame: 6 months ]
From date of stent implantation until the date of 6 month follow-up visit, or date of death, whichever comes first
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE X-MAS Biliary Study With Covered Biliary Stent
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Biliary Tract Cancer
Intervention  ICMJE Device: X-Suit NIR Covered Biliary Stent
Study Arms  ICMJE X-Suit NIR Covered Biliary Stent
Stent implantation in the biliary tree
Intervention: Device: X-Suit NIR Covered Biliary Stent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: July 11, 2013)
68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Israel,   Netherlands
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT01899976
Other Study ID Numbers  ICMJE Protocol Number BI-03-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medinol Ltd.
Study Sponsor  ICMJE Medinol Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medinol Ltd.
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP