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

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.

Study Overview

• Status: Completed
• Conditions: Biliary Tract Cancer
• Intervention / Treatment: Device: X-Suit NIR Covered Biliary Stent

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: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: X-Suit NIR Covered Biliary Stent; Stent implantation in the biliary tree	Device: X-Suit NIR Covered Biliary Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	6 months follow up or prior to death, whichever comes first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total number of adverse events	total number of adverse events (anticipated and unanticipated)	6 months

Collaborators and Investigators

• Sponsor: Medinol Ltd.
• Investigators: Principal Investigator: Peter D Siersema, Prof., University Medical Center Utrecht, Netherlands

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): November 13, 2017
• Study Completion (ACTUAL): November 13, 2017

Study Registration Dates

• First Submitted: July 8, 2013
• First Submitted That Met QC Criteria: July 11, 2013
• First Posted (ESTIMATE): July 16, 2013

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: covered biliary stent; X-Suit NIR Covered Biliary Stent; malignant strictures in biliary tree
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Biliary Tract Diseases; Biliary Tract Neoplasms
• Other Study ID Numbers: Protocol Number BI-03-01