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Steam therapy for enlarged prostate: a new hope?

NCT ID NCT05201131

Disease control Sponsor: Can-Am HIFU Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial is testing a procedure called Rezūm, which uses steam to shrink excess prostate tissue in men with benign prostatic hyperplasia (BPH), a common cause of urinary problems. About 50 men will receive the treatment, and researchers will track changes in urine flow, residual urine, prostate size, and symptom scores over time. The goal is to see if this minimally invasive approach safely improves urinary symptoms in a Canadian population.

What this could mean

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

Active substance
Rezūm system (convective thermal therapy using water vapor)
What this could lead to
If successful, this could provide a minimally invasive option to relieve BPH symptoms and improve urine flow, potentially reducing the need for more invasive surgery.
What could go wrong
This is a small, non-randomized study, so results may not apply broadly. Possible risks include temporary urinary discomfort, bleeding, or infection, and the therapy may not work for everyone.

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.

Participants

About 50 people

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

Started

Oct 2019

Expected to finish

Dec 2029

An estimate. End dates often move.

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.

Who is studied

* Male subjects of ≥ 18 years of age. * Primary diagnosis of Benign Prostate Hypertrophy (BPH). * Candidate for or have already completed Rezūm therapy as per clinical decision of Investigator.

Ages

18 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 Criteria: * Male subjects of ≥ 18 years of age. * Primary diagnosis of Benign Prostate Hypertrophy (BPH). * Candidate for Rezūm therapy as per clinical decision of Investigator. * Willing and able to accurately complete the required questionnaires. * Willing and able to provide signed and dated informed consent Exclusion Criteria: * Characteristics indicating a poor compliance with study protocol requirements. * Disease or other health condition that is not suitable for this study. * Unable or unwilling to provide signed informed consent.

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia urinary system disorder

As listed by the trial registrant

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

Urologic diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Dean Elterman

    RECRUITING

    Toronto, Ontario, M5T 2S8, Canada

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