The HANAROSTENT® Multi-Hole™ Biliary Stent is Indicated for Use in the Palliative Treatment of Biliary Strictures Produced by Malignant Neoplasms and the Study is to Demonstrate Clinical Safety and Performance of the Multi-Hole™ Stent for the Palliative Treatment of Malignant Biliary Obstruction.

ConditionBiliary Strictures Caused by Malignant Neoplasms

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorOlympus Corporation of the Americas

About this trial

The objective of this study is to demonstrate clinical safety and performance of the HANAROSTENT® Multi-Hole™ Biliary Stent for the palliative treatment of malignant biliary obstruction.

Eligibility criteria

Qualifiers

Suspected or confirmed malignant non-hilar extrahepatic biliary obstruction including any of the following measures of biliary obstruction or patients undergoing neoadjuvant cancer treatment (chemotherapy and/or radiation) for malignant biliary obstruction

Disqualifiers

Participation in another investigational study within 90 days prior to consent

Trial design

Treatments tested in this trial

Biliary Stent for the Palliative Treatment of Malignant Biliary Obstruction

Treatment groups

No treatment groups listed

Locations

This trial has no locations

Sponsors and collaborators

Olympus Corporation of the Americas

Lead sponsor

Mayo Clinic

Collaborator

M.I.Tech Co., Ltd.

Collaborator

Source ClinicalTrials.gov