Trials / Unknown
UnknownNCT03885310
INGEST I Pilot Study
Gastrointestinal Drug-Coated Balloon for the Treatment of Symptomatic Recurrent Benign Esophageal Stricture
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- GIE Medical · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
INGEST 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 esophageal stricture. Up to 30 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 with a 3 stage inflatable balloon coated with a proprietary coating containing the drug and carriers. |
Timeline
- Start date
- 2019-02-24
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2019-03-21
- Last updated
- 2022-08-10
Locations
1 site across 1 country: Paraguay
Source: ClinicalTrials.gov record NCT03885310. Inclusion in this directory is not an endorsement.