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 — DEVICE
    Has 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: Optilume
    Treatment 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

Locations (7)

FacilityCityStateZIPSite coordinators
University of California IrvineOrangeCalifornia92868
Jaime Landman, MD
9498249320
Jaime Landman, MD (PRINCIPAL_INVESTIGATOR)
Orlando HealthOrlandoFlorida32806
Lucas Wiegand, MD
877-876-3627
Lucas Wiegand, MD (PRINCIPAL_INVESTIGATOR)
Indiana UniversityIndianapolisIndiana46202
Matthew Mellon, MD
317-962-8401
Mount SinaiNew YorkNew York10003
Michael Palese, MD
212-844-8900
Michael Palese, MD (PRINCIPAL_INVESTIGATOR)
NYU LangoneNew YorkNew York10016
Lee Zhao, MD
646-825-6300
University of Texas SouthwesternDallasTexas75390
Maia VanDyke, MD
214-645-8765
Maia VanDyke, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84112
Benjamin McCormick, MD
801-213-2718
Benjamin McCormick, MD (PRINCIPAL_INVESTIGATOR)

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