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

Completed

• Conditions: clinical symptoms of biliary obstruction and inoperable extrahepatic biliary obstruction by any malignant process; 10004606

• Registration Number: NL-OMON41690
• Lead Sponsor: Medinol Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

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).
Malignancy is defined as:
• A tissue diagnosis (biliary brushing or percutaneous biopsy, EUS,
FNA), or
• Elevated serum tumor markers (CEA, CA19-9, AFP), or
• Presence of liver metastasis per CT scan or MRI.
4. .Subject is willing and able to comply with the study procedures and
provide written informed consent to participate in the study

Exclusion Criteria

The subject must not meet any of the following exclusion criteria:
1. Participation in an Investigational Study within 30 days prior to date of subject consent.
2. Perforation of any duct within the biliary tree.
3. Presence of more than three previously implanted plastic stent.
4. 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. Pregnant women and breast-feeding women.
13. Subjects considered to be vulnerable i.e. prisoners and individuals with impaired consent capacity and/or lack or loss of autonomy.;Cholangiographic exclusion criterion:
14. Strictures that cannot be passed by the guide wire or the delivery system.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1 Primary Endpoint<br /><br>The primary outcome measured will be the adequate clinical palliation of the<br /><br>biliary obstruction, as demonstrated by:<br /><br>• The maintenance of a total serum bilirubin level <= 3.0 mg/dL or a reduction<br /><br>of >30% if baseline value was greater than 3.0 mg/dL, and<br /><br>• The absence of recurrent biliary obstruction, defined as the absence of<br /><br>clinical signs and symptoms of cholangitis (such as fever, worsening abdominal<br /><br>pain), or absence of worsening liver enzymes, at 6 months follow-up or prior to<br /><br>death, whichever comes first. </p><br>