A Study to Evaluate the Safety of HANAROSTENT® Biliary Flap Lasso Stent System Use to Treat Cancer Patients with Biliary Obstruction

Overview

About this study

The purpose of this study is to demonstrate clinical performance and safety of the fully covered (FC) HANAROSTENT® Biliary Flap Lasso Stent System with anti-migration flaps for the palliative treatment of malignant biliary obstruction.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Presence of inoperable malignant nonhilar extrahepatic biliary obstruction.
Clinical symptoms of biliary obstruction.
≥ 18 years of age.
Willing and able to provide informed consent.

Exclusion Criteria:

Participation in another investigational study within 90 days prior to consent.
Strictures that could not be traversed by the delivery system.
Perforation of any duct within the biliary tree.
Presence of a biliary SEMS.
Presence of any esophageal or duodenal stent.
Contraindications to endoscopy.
Sensitivity to any components of the stent or delivery system.
Active hepatitis.
Intrahepatic metastases that extensively involve both lobes of the liver.
Life expectancy of < 3 months.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Ryan Law, D.O.	Closed-enrolling by invitation What is this? (?) "Close" Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.	Contact information: Elizabeth Lemke M.P.H. (507) 255-7495 Lemke.Elizabeth@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ryan Law, D.O.

Closed-enrolling by invitation

Contact information:

Elizabeth Lemke M.P.H.

(507) 255-7495

Lemke.Elizabeth@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials