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

Overview

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

Interventions

• Device Optilume
  Has pre-treatment (balloon dilation or ureterotomy) followed by paclitaxel-coated balloon (Optilume) treatment of the ureteric stricture.

Primary outcome measures

• Successful treatment [Time frame: 6-months post ureteral stent removal (approximately 7 months post Optilume treatment)]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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
• Presence of any condition that precludes administration of furosemide during renograms
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 7 centers

• University of California Irvine — Orange
• Orlando Health — Orlando
• Indiana University — Indianapolis
• Mount Sinai — New York
• NYU Langone — New York
• University of Texas Southwestern — Dallas
• University of Utah — Salt Lake City

Identifiers

NCT: NCT07020520 · 1391

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗