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

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 Overview

• Status: Enrolling by invitation
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: ALPFA BPH PFA System

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia
    • Brno University Hospital
  • Hradec Králové, Czechia
    • Urologicka Klinika
• Italy
  • Milan, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda
• Panama
  • Panama City, Panama
    • Pacifica Salud Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm	Device: ALPFA BPH PFA System; PFA system for treatment of Benign Prostatic Hyperplasia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Collaborators and Investigators

• Sponsor: ALPFA Medical

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 27, 2025
• First Submitted That Met QC Criteria: May 2, 2025
• First Posted (Actual): May 11, 2025

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia
• Other Study ID Numbers: CS-00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes