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DIGEST I Drug Coated Balloon for Biliary Stricture — DIGEST  

Biliary Stricture Clinical Trial

Official title:
Drug-Coated Balloon for the Treatment of Symptomatic Chronic Benign Biliary Stricture

Clinical Trial Summary

DIGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.

Clinical Trial Description

The study is designed to determine the safety and effectiveness of drug coated balloon (DCB) treatments on biliary tract stricture. Up to 15 subjects are planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03997994
Study type Interventional
Source GIE Medical
Contact
Status Active, not recruiting
Phase N/A
Start date May 12, 2019
Completion date March 21, 2025
View Details
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