New pulsed field ablation device aims to relieve prostate troubles
NCT ID NCT06965582
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study is testing a new device that uses pulsed field ablation to treat urinary symptoms caused by an enlarged prostate (BPH). About 100 men over age 45 who haven't gotten relief from medication will receive the treatment and be followed for safety and effectiveness. The goal is to see if this approach can safely improve symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ALPFA BPH Pulsed Field Ablation (PFA) System
- What this could lead to
- If successful, this device could offer a new, less invasive option to relieve bothersome urinary symptoms caused by an enlarged prostate.
- What could go wrong
- This is a small, early pilot study with no comparison group, so results may not be conclusive. The procedure also carries risks of serious side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites in 3 countries. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
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Brno University Hospital
Brno, Czechia
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Pacifica Salud Hospital
Panama City, Panama
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Urologicka Klinika
Hradec Králové, Czechia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Steam therapy vs. surgery: can a less invasive fix help men with blocked urine flow?
- Listening to patients: a new way to guide prostate treatment?
- A surgical twist that could save ejaculation during prostate surgery
- Water jet surgery: a new wave for prostate relief?