Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT03997994
Brief Summary:
DIGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.
Detailed 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:
NCT03997994
Study Brief:
Protocol Section:
NCT03997994