Enrolling by invitation

ALPFA PFA System for Symptomatic Benign Prostatic Hyperplasia in Men Over 45

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What is being tested

ALPFA BPH PFA System

Device
Who is being recruted

Urogenital Diseases+3

+ Genital Diseases

+ Genital Diseases, Male

Over 45 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2025
See protocol details

Summary

Principal SponsorALPFA Medical
Last updated: March 17, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 7, 2025

Actual date on which the first participant was enrolled.

This study is investigating a new treatment method for men over 45 who experience difficulty urinating due to an enlarged prostate, a condition known as Benign Prostatic Hyperplasia (BPH). The study is focused on evaluating the safety and effectiveness of the ALPFA BPH Pulsed Field Ablation (PFA) System. This system aims to provide relief from urinary symptoms by using a specific technique to treat the prostate. The study is important because it may offer a new option for managing BPH symptoms, which can significantly affect quality of life. Participants in the study will first undergo initial tests to ensure they meet the requirements to join. Those who qualify will receive treatment with the ALPFA BPH PFA System, a procedure that is part of the study protocol. After treatment, participants will have scheduled follow-up visits to monitor their progress and assess how well the treatment is working. The study does not specify any particular risks or benefits, as it is in the early stages, but close monitoring will help ensure participant safety.

Official TitleA Pilot Study Of The ALPFA Benign Prostatic Hyperplasia (BPH) Pulsed Field Ablation (PFA) System In Men With Symptomatic Benign Prostatic Hyperplasia
NCT06965582
Principal SponsorALPFA Medical
Last updated: March 17, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleProstatic DiseasesProstatic HyperplasiaMale Urogenital Diseases

Criteria

Inclusion: 1. Patients who are ≥ 45 years of age on the day of enrollment. 2. Patients who have failed to achieve satisfactory resolution of BPH symptoms using an approved medication. 3. Life expectancy: the patient has a life expectancy of ≥ 1 year 4. Patient participation: The patient 1. is free of physical, psychological or other impairment that would prevent their ability to understand and comply with all study requirements. 2. is willing and capable of providing Informed Consent to undergo study procedures. 3. agrees to fully participate in all examinations, study requirements, follow-up visits and tests associated with this clinical study. 4. lives close enough to the investigational site to facilitate the required in-person visits. Exclusion: 1. Urologic conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to: 1. Previous operative intervention for BPH 2. Active urinary tract infection (may be treated and enrolled upon negative urine culture). 3. Prostatitis: a history of any prostatitis within 2 years of enrollment. 4. Cystolithiasis active within 90 days of enrollment 5. artificial sphincters. 2. Bladder cancer: a history of treated bladder cancer of Stage T2 or higher, or a clinical suspicion of bladder cancer 3. Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to: a. Unstable cardiovascular disease including: i. NYHA III/IV heart failure or LVEF \< 40% ii. Uncontrolled arrhythmia iii. Stroke, TIA, thromboembolic event, myocardial infarction, unstable angina, percutaneous coronary intervention or any cardiac surgery within 90 days of enrollment iv. Uncontrolled hypertension b. Immunosuppression: Known immunosuppression, including but not limited to AIDS, immunosuppressive medication or current chemotherapy. c. Coagulopathy: Diagnosed disorder of blood clotting or bleeding diathesis. d. Transplant: History of any solid organ or hematologic transplant, or currently being evaluated for an organ transplant e. Active substance abuse: active alcoholism or

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

Brno University Hospital

Brno, CzechiaOpen Brno University Hospital in Google Maps
Suspended

Urologicka Klinika

Hradec Králové, Czechia
Suspended

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy
Suspended

Pacifica Salud Hospital

Panama City, Panama
Enrolling by invitation4 Study Centers