Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-30 @ 10:45 AM
Study NCT ID:
NCT03997994
Status:
UNKNOWN
Last Update Posted:
2022-08-17
First Post:
2019-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DIGEST I Drug Coated Balloon for Biliary Stricture
Sponsor:
GIE Medical
Organization:
Study Overview
Official Title:
Drug-Coated Balloon for the Treatment of Symptomatic Chronic Benign Biliary Stricture
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIGEST
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: