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

NCT06965582 | Enrolling By Invitation FDA Device

• 1 other identifier: CS-00001
• Study Type: interventional
• Target: 100
• Locations: 3 countries
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Device: ALPFA BPH PFA System

Interventions

ALPFA BPH PFA System DEVICE

PFA system for treatment of Benign Prostatic Hyperplasia

Treatment Arm

Eligibility Criteria

• Age: 45 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are ≥ 45 years of age on the day of enrollment.
• Patients who have failed to achieve satisfactory resolution of BPH symptoms using an approved medication.
• Life expectancy: the patient has a life expectancy of ≥ 1 year
• Patient participation: The patient
• is free of physical, psychological or other impairment that would prevent their ability to understand and comply with all study requirements.
• is willing and capable of providing Informed Consent to undergo study procedures.
• agrees to fully participate in all examinations, study requirements, follow-up visits and tests associated with this clinical study.
• lives close enough to the investigational site to facilitate the required in-person visits.

You may not qualify if:

• 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:
• Previous operative intervention for BPH
• Active urinary tract infection (may be treated and enrolled upon negative urine culture).
• Prostatitis: a history of any prostatitis within 2 years of enrollment.
• Cystolithiasis active within 90 days of enrollment
• artificial sphincters.
• Bladder cancer: a history of treated bladder cancer of Stage T2 or higher, or a clinical suspicion of bladder cancer
• 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

Sponsors & Collaborators

• ALPFA Medical: lead

Study Sites (4)

Brno University Hospital

Brno, Czechia

Location

Urologicka Klinika

Hradec Králové, Czechia

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

Location

Pacifica Salud Hospital

Panama City, Panama

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 11, 2025
• Study Start: February 7, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); PA (1); CZ (2)