EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures

Recruiting now · Not applicable

Conditions studied: Ureteral Stricture

In brief

The main objective of this clinical investigation is to assess the safety and feasibility of the Optilume DCB for treatment of ureteric strictures.

Key facts

Study ID

NCT07020520

Run by

Urotronic Inc.

People needed

60

Starts

2025-10-01

Expected to finish

2031-07-30

Last updated by the study team

2026-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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 as measured by functional renogram or other significant pathology or impairment that may impact renal function
• Life expectancy less than 12 months
• Women who are pregnant or breastfeeding
• Women of child-bearing potential planning to get pregnant in the next year or are unwilling to use contraception over the next 12 months
• Males unwilling to abstain or use protected sex for 30 days post treatment
• Males unwilling to use highly effective contraception for6 months post treatment if sexual 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 investigation of a medical device, drug, or biologic (excluding registries) that may confound the results of the trial
• Active systemic or urinary tract infection
• Active malignancy in the abdomen or pelvis, or any malignancy considered considerable risk for metastasizing to the abdomen or pelvis over the next 12 months
• Uncontrolled diabetes defined as hemoglobin A1C ≥ 8% at baseline
• Unable to come off antiplatelet or anticoagulation medication prior to treatment to prevent bleeding complications at the discretion of the investigator
• Any other condition that may confound the results of the trial or presents an unacceptable risk for any study-related procedure
• Individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response

Where it is running

• University of California Irvine — Orange, California, United States (enrolling)
• Orlando Health — Orlando, Florida, United States (enrolling)
• Indiana University — Indianapolis, Indiana, United States (enrolling)
• Mount Sinai — New York, New York, United States (enrolling)
• NYU Langone — New York, New York, United States (enrolling)
• University of Texas Southwestern — Dallas, Texas, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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