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New treatment option for Ureteral Stricture
Official title EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures
ClinicalTrials.gov ID: NCT07020520
What this study is testing
- What it's testing
- The main objective of this clinical investigation is to assess the safety and feasibility of the Optilume DCB for treatment of ureteric strictures.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join if
- Treatment of the target ureter with incision or balloon dilation within 3 months of the study treatment
- people with more than one ureteric stricture
- people 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
See the full eligibility 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
- Treatment of the target ureter with incision or balloon dilation within 3 months of the study treatment
- people with more than one ureteric stricture
- people 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 treatment 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- Orlando, Florida, United States
- Indianapolis, Indiana, United States
- New York, New York, United States
- Dallas, Texas, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; Orlando, Florida, United States; Indianapolis, Indiana, United States; New York, New York, United States; Dallas, Texas, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.