Trials / Unknown
UnknownNCT03886324
POISE I Pilot Study
Paclitaxel-Coated Balloon for the Treatment of Symptomatic Recurrent Benign Intestinal Stricture
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- GIE Medical · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
POISE I study is a feasibility study for evaluating the safety and efficacy of DCB.
Detailed description
The study is designed to determine the safety and effectiveness for drug coated balloon (DCB) for treating intestinal strictures. 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 |
|---|---|---|
| COMBINATION_PRODUCT | GIE Medical Drug Coated Balloon | Stricture patients treated by DCB |
Timeline
- Start date
- 2019-02-25
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2019-03-22
- Last updated
- 2022-08-17
Locations
1 site across 1 country: Paraguay
Source: ClinicalTrials.gov record NCT03886324. Inclusion in this directory is not an endorsement.