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

Urology
Jaime Landman
Evaluation of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures
Urology

Study Description

Eligibility

  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
  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 less than 30 mL/min/1.73m2
  10. Kidney function less than or equal to 25% of split function on the side with target stricture as measured by functional renogram
  11. Kidney function less than or equal to 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 greater than or equal to 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

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