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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
PFA system for treatment of Benign Prostatic Hyperplasia
Brno University Hospital
Brno, Czechia
Urologicka Klinika
Hradec Králové, Czechia
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Pacifica Salud Hospital
Panama City, Panama
Primary Safety Outcome
The safety endpoint for this study is a Composite Safety Endpoint (CSE) defined as the proportion of subjects with one or more device- or procedure-related serious adverse events (SAEs) through 30 days post-procedure.
Time frame: 30 days
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