CompletedNot Applicable

X-MAS Biliary Study With Covered Biliary Stent

Belgium, Israel68 participantsStarted 2013-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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).

What they're measuring

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

Timeframe: 6 months follow up or prior to death, whichever comes first

Trial details

NCT IDNCT01899976

SponsorMedinol Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-11-13

View on ClinicalTrials.gov More Biliary Tract Cancer trials