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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.

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.

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Device: X-Suit NIR Covered Biliary Stent Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
X-Suit NIR Covered Biliary Stent
Stent implantation in the biliary tree
Device: X-Suit NIR Covered Biliary Stent



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899976


Locations
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Belgium
Hôpital Erasme Brussels (ULB)
Brussels, Belgium, 1070
Israel
Hillel Yafeh Medical Center
Hadera, Israel, 38100
Rambam Medical Center
Haifa, Israel, 31096
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Haddasah Medical Center
Jerusalem, Israel, 91120
Sheba Medical Center, Tel Hashomer
Ramat Gan, Israel, 52621
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Netherlands
University Medical Center Utrecht
Utrecht, Heidelberglaan, Netherlands, 100, 3584 CX
Academic Medical Center (AMC)
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Medinol Ltd.

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Responsible Party: Medinol Ltd.
ClinicalTrials.gov Identifier: NCT01899976     History of Changes
Other Study ID Numbers: Protocol Number BI-03-01
First Posted: July 16, 2013    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016

Keywords provided by Medinol Ltd.:
covered biliary stent
X-Suit NIR Covered Biliary Stent
malignant strictures in biliary tree

Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases