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

Launched by UROTRONIC INC. · Jun 4, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option called the Optilume Drug-Coated Balloon (DCB) for patients with ureteric strictures. A ureteric stricture is a narrowing of the tube that carries urine from the kidneys to the bladder, which can cause pain and other urinary issues. The main goal of the study is to see if this treatment is safe and effective for patients who have one specific type of stricture that is 4 centimeters long or shorter.

To participate, individuals must be at least 18 years old and have two functioning kidneys. However, there are several criteria that could exclude someone from participating, such as if they've had recent treatments for the stricture or have multiple strictures. Participants can expect to undergo a procedure using the Optilume DCB, and they will be monitored closely for safety and treatment outcomes. This trial is not yet recruiting, so there’s no current opportunity to join, but it aims to provide valuable information for future treatments of ureteric strictures.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 years or older
• • 2. Single lesion ureteric or uretero-enteric stricture less than or equal to 4.0 cm in length
• • 3. Two functioning kidneys
• Exclusion Criteria:
• • 1. Treatment of the target ureter with incision or balloon dilation within 3 months of the study treatment
• • 2. Subjects with more than one ureteric stricture
• • 3. Subjects with target stricture in bifid or duplicated ureter
• • 4. Known sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
• • 5. Ureteric stricture caused by extrinsic compression of the ureter
• • 6. Unable to endoscopically access target stricture for any reason
• • 7. Existing stones in the ipsilateral kidney or ureter (except for asymptomatic kidney stones) that are in close proximity to the target ureteric stricture
• • 8. Chronic renal failure treated with dialysis
• • 9. eGFR \<30 mL/min/1.73m2
• • 10. Kidney function ≤ 25% of split function on the side with target stricture as measured by functional renogram
• • 11. 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
• • 12. Life expectancy less than 12 months
• • 13. Women who are pregnant or breastfeeding
• • 14. Women of child-bearing potential planning to get pregnant in the next year or are unwilling to use contraception over the next 12 months
• • 15. Males unwilling to abstain or use protected sex for 30 days post treatment
• • 16. Males unwilling to use highly effective contraception for6 months post treatment if sexual partner(s) are of child-bearing potential
• • 17. Inability to provide legally effective informed consent
• • 18. Unwilling or unable to meet protocol follow-up requirements
• • 19. Participation in any interventional clinical investigation of a medical device, drug, or biologic (excluding registries) that may confound the results of the trial
• • 20. Active systemic or urinary tract infection
• • 21. 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
• • 22. Uncontrolled diabetes defined as hemoglobin A1C ≥ 8% at baseline
• • 23. Unable to come off antiplatelet or anticoagulation medication prior to treatment to prevent bleeding complications at the discretion of the investigator
• • 24. Any other condition that may confound the results of the trial or presents an unacceptable risk for any study-related procedure
• • 25. 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
• • 26. Presence of any condition that precludes administration of furosemide during renograms
• • 27. Unable to tolerate contrast related to required study procedures or imaging.
• • Additional Criteria for Pharmacokinetic Substudy Inclusion Ureteric stricture measurements appropriate for treatment with a 6mm (18F) or 8mm (24F) diameter Optilume DCB Exclusion Prior treatment with any device or medical therapy that contains paclitaxel, including drug coated balloons for vascular and urethral applications