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New Needle-Free prostate treatment could replace surgery

NCT ID NCT05306145

Disease control Sponsor: Shanghai East Hospital Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study compares a new procedure called high-frequency irreversible electroporation (H-FIRE) to standard surgery (TURP) for treating benign prostatic hyperplasia (enlarged prostate). 118 men aged 40 and older with moderate to severe symptoms are participating. H-FIRE uses electrical pulses to destroy excess prostate tissue without cutting, while TURP surgically removes tissue. The goal is to see if H-FIRE is as effective at improving urine flow and symptoms, with potentially fewer side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
High frequency irreversible electroporation (H-FIRE) procedure
What this could lead to
If H-FIRE works as well as TURP but with fewer side effects, it could offer men with enlarged prostate a less invasive treatment option.
What could go wrong
This is a small, single-center trial with 118 participants, so results may not apply to everyone. H-FIRE is still experimental and may not be as effective or safe as standard surgery.

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

118 people

The number who actually took part.

Started

Jun 2022

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 Criteria: 1. Age over 40 years old 2. IPSS\>8 3. Qmax \<15ml/s 4. Prostatic volume range of 30 to 100ml, measured by MRI 5. Fully understand the clinical trial protocol and sign the informed consent Exclusion Criteria: Have a history of prostate cancer or patients suspicious of prostate cancer Neurogenic bladder Metal implants in their body Previous history of prostatic or urethral surgery With Catheterisation more than 2 weeks Any other conditions that investigator judges that participations who are not suitable for this trial

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Benign prostatic hyperplasia

Contacts and locations

Locations

  • Haifeng Wang

    Shanghai, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.