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New pulsed field ablation device aims to relieve prostate troubles

NCT ID NCT06965582

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

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

45 years and older

Sex

Male participants only

Healthy volunteers

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

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.

  1. The places running it

    4 sites in 3 countries. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Brno University Hospital

    Brno, Czechia

  • Pacifica Salud Hospital

    Panama City, Panama

  • Urologicka Klinika

    Hradec Králové, Czechia

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