Actively Recruiting
EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures
Led by Urotronic Inc. · Updated on 2026-03-09
60
Participants Needed
7
Research Sites
304 weeks
Total Duration
On this page
Sponsors
U
Urotronic Inc.
Lead Sponsor
L
Laborie Medical Technologies Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main objective of this clinical investigation is to assess the safety and feasibility of the Optilume DCB for treatment of ureteric strictures.
CONDITIONS
Official Title
EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Single lesion ureteric or uretero-enteric stricture less than or equal to 4.0 cm in length
- Two functioning kidneys
You will not qualify if you...
- Treatment of the target ureter with incision or balloon dilation within 3 months of the study treatment
- More than one ureteric stricture
- Target stricture in bifid or duplicated ureter
- Known sensitivity to paclitaxel or on medication that may negatively interact with paclitaxel
- Ureteric stricture caused by external compression
- Unable to endoscopically access target stricture
- Existing stones near the target stricture except asymptomatic kidney stones
- Chronic renal failure treated with dialysis
- eGFR less than 30 mL/min/1.73m2
- Kidney function 25% or less on the side with the target stricture
- Kidney function 35% or less on the opposite side or significant impairment
- Life expectancy less than 12 months
- Women who are pregnant or breastfeeding
- Women planning pregnancy within 12 months or unwilling to use contraception
- Males unwilling to abstain or use protection for 30 days post treatment
- Males unwilling to use effective contraception for 6 months if partner can conceive
- Unable to provide informed consent
- Unwilling or unable to follow up per protocol
- Participation in other interventional clinical trials that may affect results
- Active systemic or urinary tract infection
- Active malignancy in abdomen or pelvis or risk of metastasis
- Uncontrolled diabetes with hemoglobin A1C 8% or higher
- Unable to stop antiplatelet or anticoagulation medication before treatment if needed
- Any condition that may confound results or increase risk
- Unable to understand or consent properly
- Conditions preventing use of furosemide during renograms
- Unable to tolerate contrast for study imaging
- Prior treatment with paclitaxel devices or therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
University of California Irvine
Orange, California, United States, 92868
Actively Recruiting
2
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
3
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
4
Mount Sinai
New York, New York, United States, 10003
Actively Recruiting
5
NYU Langone
New York, New York, United States, 10016
Actively Recruiting
6
University of Texas Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
7
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
S
Steven M Principal Clinical Project Manager
CONTACT
R
Reem Ennenga
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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