Evaluation of Optilume Drug-Coated Balloon for the Endoscopic Treatment of Ureteric Strictures
Investigating Treatment for Narrowing in the Tubes Carrying Urine with an Investigational Device
Matthew Mellon, MD
Primary Investigator
Brief description of study
The main objective of this clinical investigation is to assess the safety and feasibility of the Optilume DCB for treatment of ureteric strictures. Other objectives include characterizing the following through descriptive analysis:
• Adverse event profile
• Improvement in flank pain
• Renal function changes
• Improvement in hydronephrosis
• Need for retreatment
• Pharmacokinetics of paclitaxel in the blood and urine
Detailed description of study
This is a noninterventional, biorepository, sample collection study in plwALS, and in non-
ALS participants. Health status, disease history, and updates will also be collected throughout the study.
Samples, assessments and concomitant therapies will be analyzed to determine any correlations with ALS
disease progression over time, and when compared to non-ALS participants. Non-ALS participants will
ideally be recruited from the caregivers of plwALS.
Participants will be screened, enrolled, and then followed for up to 36 months (3 years). Study visits will
take place within the normal cadence of regular neurology check-ups, estimated to be every 3 months
± 1 month.
The planned study duration for enrolled participants is 3 years. Total study duration will be from screening
of the first participant until the last follow-up of the last participant; this is estimated as 7 years initially.
• Screening - 1 clinic visit
• Study participation (sample and data collection) – clinic visits every 3 months, for up to 3 years.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Uretric stricture
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Age: 18 years - 100 years
-
Gender: All
Inclusion:
1. Male or female participants aged ≥18 years
2. Can visit study site for required clinic visits
3. Willing and able to provide informed consent prior to any study procedures being performed
4. Are reliable and willing to be available for the duration of the study and follow study procedures
5. For plwALS only - Diagnosis of ALS, by either Gold Coast Criteria or El Escorial Criteria (possible,
probable laboratory supported, probable, or definite)
Exclusion:
1. Cannot communicate reliably with the Investigator
2. Is not suitable for inclusion in the study, in the opinion of the Investigator
This study investigates the use of an investigational device for treating ureteric strictures, which are narrowings in the ureter that can cause blockage of urine flow. The purpose of this study is to evaluate the safety and feasibility of using this device to treat these strictures. The study will also look at the occurrence of side effects, changes in kidney function, and improvement in symptoms such as flank pain and hydronephrosis, which is swelling of the kidney due to urine buildup.
Participants will undergo regular assessments to monitor their condition and the effects of the treatment. The study will collect information from these assessments to understand how the investigational device affects the body, including the presence of paclitaxel, a drug used in the device, in the blood and urine. Participants will be asked to attend clinic visits and provide samples as part of the study procedures.
- Who can participate: Adults aged 18 years and older who can attend clinic visits and provide informed consent are eligible. Key eligibility includes the ability to follow study procedures and availability for the study duration.
- Study details: Participants will attend clinic visits and provide samples as part of the study. Data will be collected to understand the impact of the investigational device on ureteric strictures.
- Study timelines and visits: The study will last 3 years. The study requires clinic visits every 3 months.
