DIGEST I Pilot Study (DIGEST)

  • STATUS
    Recruiting
  • End date
    Mar 21, 2025
  • participants needed
    15
  • sponsor
    GIE Medical
Updated on 8 August 2021
stenosis
balloon dilatation
total serum bilirubin
endoscopic retrograde cholangiopancreatography
liver transplantation
balloon dilation

Summary

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

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.

Details
Condition Gallbladder Disease, Biliary Stricture, Biliary Obstruction, Gall Bladder Disorders, Biliary Anastomotic Stenosis, biliary disease, gall bladder, biliary tract obstruction
Treatment GIE Drug Coated Balloon
Clinical Study IdentifierNCT03997994
SponsorGIE Medical
Last Modified on8 August 2021

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