A Prospective Randomized Pivotal Trial of the ALPFA Medical Prostate Ablation System Compared With Cystoscopy in Men With Symptomatic Benign Prostatic Hyperplasia
ALPFA Medical
Summary
The main goal of this study is to evaluate the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System for treatment of enlarged prostate (BPH) symptoms. The study will involve up to 250 male participants who have urinary problems caused by BPH and whom are greater than 40 years of age in up to 30 investigational centers across the US,Canada and European Union.
Description
This study aims to test how safe and effective the ALPFA BPH PFA System is for treating men over age 40 who have urinary problems caused by an enlarged prostate (BPH).The study will involve up to 250 participants in up to 30 investigational centers across the US, Canada, and European Union. Men who agree to join the study will have health checks before treatment. Those who meet the study eligibility criteria including medication washout requirements,will be placed by chance into one of two groups. Two out of three men will receive treatment with the ALPFA BPH PFA System. One out of three men…
Eligibility
- Age range
- 45+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: Study subjects are required to meet all the following inclusion criteria to participate in this study as determined by the Investigator: 1. ≥ 45 years of age on the day of enrollment. 2. Symptomatic BPH meeting all of the following criteria determined within 30 days preceding enrollment and after fulfilling the concomitant medication washout period(s): 1. Symptom Score: Baseline IPSS score ≥13 2. Flow Rate: Uroflow test with a pre-void bladder volume ≥150 mL (confirmed by bladder scan),Single uroflow test with a minimum voided volume ≥ 125 mL and a Qmax ≥ 5 mL/sec a…
Interventions
- DeviceTreatment Device: The ALPFA Medical (ALPFA) GRAIL™ Pulsed Field Ablation (PFA) System
After the participant receives anesthesia, the Investigator will proceed with placement of the ALPFA GRAIL PFA Catheter into the prostate via a standard flexible cystoscope. Visualization of the prostatic urethra will determine the number of balloons that are exposed and inflated. When the catheter has been properly positioned, the ALPFA GRAIL PFA Console will be activated and one PFA application will be delivered. The Investigator will assess if the catheter needs to be repositioned and additional ablation applications delivered, as necessary. Once ablation is complete, the catheter balloons will be deflated, and the catheter will be withdrawn from the urethra. Participants will then have follow-up visits with health checks as planned for this study.
- DeviceControl Device: Sham flexible cystoscopy
Participants will receive mock treatment with a flexible cystoscope with a working channel that is at least 6.9F in diameter. The cystoscope will be inserted and treatment script initiated. Once the script is completed, the cystoscope will be removed and procedural details captured on the relevant CRF. Participants will then have follow-up visits with health checks as planned for this study.
Location
- The Conrad Pearson ClinicGermantown, Tennessee