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ENROLLING BY INVITATION
NCT06965582
NA

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

Sponsor: ALPFA Medical

View on ClinicalTrials.gov

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

Interventions

DEVICE

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