Clinical trial NCT01899976: 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
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Tract Cancer
Keywords: covered biliary stent
X-Suit NIR Covered Biliary Stent
malignant strictures in biliary tree
Lead sponsor: Medinol Ltd.
Sponsor class: INDUSTRY
First posted: 2013-07-16
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: total number of adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Erasme Brussels (ULB)
city: Hadera
country: Israel
facility: Hillel Yafeh Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Haddasah Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center, Tel Hashomer
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
state: Heidelberglaan
city: Amsterdam
country: Netherlands
facility: Academic Medical Center (AMC)
Study officials:
affiliation: University Medical Center Utrecht, Netherlands
name: Peter D Siersema, Prof.
role: PRINCIPAL_INVESTIGATOR
References: