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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06965582
Enrollment
100
Registered
2025-05-11
Start date
2025-02-07
Completion date
2030-03-01
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Keywords

prostate, BPH

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.

Interventions

PFA system for treatment of Benign Prostatic Hyperplasia

Sponsors

ALPFA Medical
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Primary Safety Outcome30 daysThe 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.

Countries

Czechia, Italy, Panama

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026