NCT06965582

A Pilot Study Of The ALPFA Benign Prostatic Hyperplasia (BPH) Pulsed Field Ablation (PFA) System

A Pilot Study Of The ALPFA Benign Prostatic Hyperplasia (BPH) Pulsed Field Ablation (PFA) System In Men With Symptomatic Benign Prostatic Hyperplasia

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: ALPFA Medical · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DEVICE	ALPFA BPH PFA System	PFA system for treatment of Benign Prostatic Hyperplasia

Timeline

• Start date: 2025-02-07
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-05-11
• Last updated: 2026-03-16

Locations

4 sites across 3 countries: Czechia, Italy, Panama

Regulatory

• FDA-regulated device study