Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study
Urotronic Inc.
Summary
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
Description
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System. STUDY ENDPOINTS Primary Efficacy Endpoint: The primary efficacy endpoint is the average IPSS improvement from baseline to 12 months. Primary Safety Endpoint: The primary safety endpoint is the freedom from composite treatment-related adverse SAEs. Key Secondary Safety Endpoint (Semen Sub-Study Only): The average change from baseline in sperm concentration at 13 weeks (3 months) post-procedure will be compared against a performance goal of -30% (30% decrease from base…
Eligibility
- Age range
- 50+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Male subject ≥ 50 years old 2. Diagnosed with lower urinary tract symptoms (LUTS) secondary to obstructive benign prostatic hyperplasia (BPH) 3. Able to be treated with the Optilume BPH Catheter System in accordance with the Instructions for Use 4. Prostate volume \< 80 g with a prostatic urethral length between 32-55 mm as determined by trans-rectal ultrasound (TRUS) 5. International Prostate Symptom Score (IPSS) ≥ 13 6. Peak urinary flow rate (Qmax) 5-15 mL/sec with minimum voided volume of 125 mL 7. Willing to provide informed consent and comply with protocol require…
Interventions
- DeviceOptilume® BPH Catheter System
The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.
Locations (5)
- Arkansas UrologyLittle Rock, Arkansas
- Florida Urology Partners, LLPTampa, Florida
- Ochsner LSU Health Shreveport - Regional UrologyShreveport, Louisiana
- Sheldon Freedman MD, LtdLas Vegas, Nevada
- Midtown Urology AssociatesAustin, Texas