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Clinical Trials/NL-OMON41690
NL-OMON41690
Completed
Not Applicable

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 - X-MAS BILIARY STUDY, PROTOCOL # BI-03-01

Medinol Ltd0 sites15 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Medinol Ltd
Enrollment
15
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

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).
  • •Malignancy is defined as:
  • •A tissue diagnosis (biliary brushing or percutaneous biopsy, EUS,
  • •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

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.

Outcomes

Primary Outcomes

Not specified

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