X-MAS Biliary Study With Covered Biliary Stent

Biliary Tract Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899976
• Other study ID #: Protocol Number BI-03-01
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: November 13, 2017

Study information

• Verified date: April 2022
• Source: Medinol Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: November 13, 2017
• Est. primary completion date: November 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Device:
• X-Suit NIR Covered Biliary Stent

Locations

Country	Name	City	State
Belgium	Hôpital Erasme Brussels (ULB)	Brussels
Israel	Hillel Yafeh Medical Center	Hadera
Israel	Rambam Medical Center	Haifa
Israel	Haddasah Medical Center	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Sheba Medical Center, Tel Hashomer	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Netherlands	Academic Medical Center (AMC)	Amsterdam
Netherlands	University Medical Center Utrecht	Utrecht	Heidelberglaan

Sponsors (1)

Lead Sponsor	Collaborator
Medinol Ltd.

Countries where clinical trial is conducted

Belgium,  Israel,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	total number of adverse events	total number of adverse events (anticipated and unanticipated)	6 months