Trials / Recruiting
RecruitingNCT07020520
EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Urotronic Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of this clinical investigation is to assess the safety and feasibility of the Optilume DCB for treatment of ureteric strictures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Optilume | Has pre-treatment (balloon dilation or ureterotomy) followed by paclitaxel-coated balloon (Optilume) treatment of the ureteric stricture. |
Timeline
- Start date
- 2025-10-01
- Primary completion
- 2027-02-28
- Completion
- 2031-07-30
- First posted
- 2025-06-13
- Last updated
- 2026-03-09
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07020520. Inclusion in this directory is not an endorsement.