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
230 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
Researchers are evaluating the safety and feasibility of the Optilume drug-coated balloon (DCB) for treating ureteric strictures, which are narrowings of the ureter. This interventional study focuses on patients with single ureteric or uretero-enteric strictures up to 4.0 cm in length and functioning kidneys. The trial is sponsored by Urotronic Inc. and aims to assess the treatment's success approximately 7 months after the procedure. Participants will receive the Optilume device treatment, which involves a pre-treatment step such as balloon dilation or ureterotomy, followed by use of the paclitaxel-coated balloon on the ureteric stricture. This single-arm study does not use masking or blinding. The study starts in October 2025 and continues until July 2031. During the trial, participants will be monitored for successful treatment outcomes at 6 months after ureteral stent removal, which is about 7 months after the Optilume treatment. Follow-up will include assessments of kidney function and imaging when needed. Participants must meet specific eligibility criteria and will be monitored for safety and treatment effectiveness throughout the study period.
CONDITIONS
Brief 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
- Subjects with more than one ureteric stricture
- Subjects with target stricture in bifid or duplicated ureter
- Known sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
- Ureteric stricture caused by extrinsic compression of the ureter
- Unable to endoscopically access target stricture for any reason
- Existing stones in the ipsilateral kidney or ureter (except for asymptomatic kidney stones) that are in close proximity to the target ureteric stricture
- Chronic renal failure treated with dialysis
- eGFR <30 mL/min/1.73m2
- Kidney function ≤ 25% of split function on the side with target stricture as measured by functional renogram
- Kidney function ≥35% of split function on the side opposite target stricture or other significant pathology affecting renal function
- Life expectancy less than 12 months
- Women who are pregnant or breastfeeding
- Women of child-bearing potential planning pregnancy in the next year or unwilling to use contraception for 12 months
- Males unwilling to abstain or use protected sex for 30 days post treatment
- Males unwilling to use highly effective contraception for 6 months post treatment if partner(s) are of child-bearing potential
- Inability to provide legally effective informed consent
- Unwilling or unable to meet protocol follow-up requirements
- Participation in any interventional clinical trial that may confound results
- Active systemic or urinary tract infection
- Active malignancy in abdomen or pelvis or risk of metastasis there within 12 months
- Uncontrolled diabetes with hemoglobin A1C ≥ 8% at baseline
- Unable to stop antiplatelet or anticoagulation medication before treatment to prevent bleeding
- Any condition that may confound trial results or pose unacceptable risk
- Unable to fully understand the investigation or vulnerable to undue influence
- Presence of any condition preventing furosemide administration during renograms
- Unable to tolerate contrast for required study procedures or imaging
- Prior treatment with any paclitaxel-containing device or therapy including drug-coated balloons for vascular or urethral use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment event
Participants receive pre-treatment (balloon dilation or ureterotomy) followed by treatment with the paclitaxel-coated Optilume balloon for the ureteric stricture.
1 treatment visit (in-person)
Duration - Approximately 7 months post-treatment
Participants are monitored after treatment including ureteral stent removal and assessment of treatment success.
Multiple follow-up visits over 7 months
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
R
Reem Ennenga
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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