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A Pilot Study Of The ALPFA Benign Prostatic Hyperplasia (BPH) Pulsed Field Ablation (PFA) System
Sponsor: ALPFA Medical
Summary
The ALPFA Medical BPH Pilot Study is a prospective, open label, single arm pilot study to assess the use of the ALPFA BPH PFA System in the treatment of men over the age of 45 with obstructive urinary symptoms associated with BPH. Male subjects will be consented and undergo protocol-defined baseline assessments. Those who meet study entry criteria will be enrolled and treated with the ALPFA BPH PFA System and then undergo follow-up with protocol-defined assessment.
Official title: A Pilot Study Of The ALPFA Benign Prostatic Hyperplasia (BPH) Pulsed Field Ablation (PFA) System In Men With Symptomatic Benign Prostatic Hyperplasia
Key Details
Gender
MALE
Age Range
45 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-02-07
Completion Date
2027-03
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
ALPFA BPH PFA System
PFA system for treatment of Benign Prostatic Hyperplasia
Locations (4)
Brno University Hospital
Brno, Czechia
Urologicka Klinika
Hradec Králové, Czechia
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Pacifica Salud Hospital
Panama City, Panama