Trials / Unknown
UnknownNCT03997994
DIGEST I Drug Coated Balloon for Biliary Stricture
Drug-Coated Balloon for the Treatment of Symptomatic Chronic Benign Biliary Stricture
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- GIE Medical · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GIE Drug Coated Balloon | The GIE DCB is a balloon catheter coated with a proprietary coating containing the drug and carriers. |
Timeline
- Start date
- 2019-05-12
- Primary completion
- 2024-03-21
- Completion
- 2025-03-21
- First posted
- 2019-06-25
- Last updated
- 2022-08-17
Locations
1 site across 1 country: Paraguay
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03997994. Inclusion in this directory is not an endorsement.