EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures
Part of paid clinical trials in Orange, California.
- Sponsor
- Urotronic Inc.
- Study ID
- NCT07020520
- Status
- Recruiting
Conditions
- Ureteral Stricture
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Optilume — DEVICEHas pre-treatment (balloon dilation or ureterotomy) followed by paclitaxel-coated balloon (Optilume) treatment of the ureteric stricture.
Study Details
The main objective of this clinical investigation is to assess the safety and feasibility of the Optilume DCB for treatment of ureteric strictures.
Key Dates
- Start date
- Oct 1, 2025
- Status verified
- Mar 2026
- Primary completion
- Feb 28, 2027
- Completion
- Jul 30, 2031
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: OptilumeTreatment with Optilume for ureteric stricture
Primary Outcome Measure
Successful treatment [ Time Frame: 6-months post ureteral stent removal (approximately 7 months post Optilume treatment) ]
Central Contacts
- Steven M Principal Clinical Project Manager952-426-6079
- Reem Ennenga
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California Irvine | Orange | California | 92868 | Jaime Landman, MD (PRINCIPAL_INVESTIGATOR) |
| Orlando Health | Orlando | Florida | 32806 | Lucas Wiegand, MD (PRINCIPAL_INVESTIGATOR) |
| Indiana University | Indianapolis | Indiana | 46202 | |
| Mount Sinai | New York | New York | 10003 | Michael Palese, MD (PRINCIPAL_INVESTIGATOR) |
| NYU Langone | New York | New York | 10016 | |
| University of Texas Southwestern | Dallas | Texas | 75390 | Maia VanDyke, MD (PRINCIPAL_INVESTIGATOR) |
| University of Utah | Salt Lake City | Utah | 84112 | Benjamin McCormick, MD (PRINCIPAL_INVESTIGATOR) |
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