Urologic DiseasesNCT05201131
Canadian Cohort of Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH).
An observational study of Urologic Diseases, run by Can-Am HIFU Inc. at 1 site in Canada.
Trial summary
To document the clinical outcome of Rezūm therapy for BPH patient in Canadian cohort. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urologic Diseases
- What is being tested?
- Rezum
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 7 Oct 2019to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: * 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Dean Elterman
Toronto, Ontario, M5T 2S8
Dean Elterman, 4166035800 ext. 5033, dean.elterman@uhn.ca
Iris Chan, 4166035800 ext. Elterman, dean.elterman@uhn.ca
About this study
To document the clinical outcome of Rezūm therapy for BPH patient in Canadian cohort.
- Conditions
- Urologic Diseases
- Being tested
- Rezum
- Keywords
- benigh prostate hypertrophy
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RezumProcedure or surgery
Rezum
| Study group | Role | What they receive |
|---|---|---|
| Rezum procedure | Not described Receives: Procedure: Rezum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum flow rate (Q-max)
Maximum flow rate (Q-max)
Measured: Baseline
Change of Maximum flow rate (Q-max)
Change of Maximum flow rate (Q-max)
Measured: 1 month after surgery
Change of Maximum flow rate (Q-max)
Change of Maximum flow rate (Q-max)
Measured: 3 months after surgery
Change of Maximum flow rate (Q-max)
Change of Maximum flow rate (Q-max)
Measured: 6 months after surgery
Change of Maximum flow rate (Q-max)
Change of Maximum flow rate (Q-max)
Measured: 12 months after surgery
Change of Maximum flow rate (Q-max)
Change of Maximum flow rate (Q-max)
Measured: 24 months after surgery
Change of Maximum flow rate (Q-max)
Change of Maximum flow rate (Q-max)
Measured: 36 months after surgery
Post-Void Residual (PVR) volume
Post-Void Residual (PVR) volume
Measured: Baseline
Change of Post-Void Residual (PVR) volume
Change of Post-Void Residual (PVR) volume
Measured: 1 month after surgery
Change of Post-Void Residual (PVR) volume
Change of Post-Void Residual (PVR) volume
Measured: 3 months after surgery
Change of Post-Void Residual (PVR) volume
Change of Post-Void Residual (PVR) volume
Measured: 6 months after surgery
Change of Post-Void Residual (PVR) volume
Change of Post-Void Residual (PVR) volume
Measured: 12 months after surgery
Change of Post-Void Residual (PVR) volume
Change of Post-Void Residual (PVR) volume
Measured: 24 months after surgery
Change of Post-Void Residual (PVR) volume
Change of Post-Void Residual (PVR) volume
Measured: 36 months after surgery
Prostate Volume measured by transrectal ultrasound (TRUS)
Prostate Volume measured by transrectal ultrasound (TRUS)
Measured: Baseline
Change of Prostate Volume measured by transrectal ultrasound (TRUS)
Change of Prostate Volume measured by transrectal ultrasound (TRUS)
Measured: 12 months after surgery
Questionnaire
IPSS
Measured: Baseline
Change of Questionnaire
Change of IPSS score
Measured: 1 month after surgery
Change of Questionnaire
Change of IPSS score
Measured: 3 months after surgery
Change of Questionnaire
Change of IPSS score
Measured: 6 months after surgery
Change of Questionnaire
Change of IPSS score
Measured: 12 months after surgery
Change of Questionnaire
Change of IPSS score
Measured: 24 months after surgery
Change of Questionnaire
Change of IPSS score
Measured: 36 months after surgery
Adverse Events
Adverse Events
Measured: Baseline
Change of Adverse Events
Change of Adverse Events
Measured: 1 month after surgery
Change of Adverse Events
Change of Adverse Events
Measured: 3 months after surgery
Change of Adverse Events
Change of Adverse Events
Measured: 6 months after surgery
Change of Adverse Events
Change of Adverse Events
Measured: 12 months after surgery
Change of Adverse Events
Change of Adverse Events
Measured: 24 months after surgery
Change of Adverse Events
Change of Adverse Events
Measured: 36 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start7 Oct 2019
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Can-Am HIFU Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dean Elterman, University Health Network, Toronto
- Investigators
- Dean Elterman, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201131
- Sponsor's protocol ID
- Rezum in BPH CAN
- Status last verified
- Aug 2026
- First submitted
- 27 Nov 2021
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Cohort of Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH).
- ClinicalTrials.gov ID
- NCT05201131
- Acronym / sponsor ID
- Rezum in BPH CAN
- Conditions
- Urologic Diseases
- Keywords
- benigh prostate hypertrophy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Can-Am HIFU Inc.University, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To document the clinical outcome of Rezūm therapy for BPH patient in Canadian cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rezum procedure | – | Procedure: Rezum |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RezumRezum | Procedure or surgery | Rezum procedure |
Primary outcome
Maximum flow rate (Q-max)
Time frame: Baseline
Maximum flow rate (Q-max)
Change of Maximum flow rate (Q-max)
Time frame: 1 month after surgery
Change of Maximum flow rate (Q-max)
Change of Maximum flow rate (Q-max)
Time frame: 3 months after surgery
Change of Maximum flow rate (Q-max)
Change of Maximum flow rate (Q-max)
Time frame: 6 months after surgery
Change of Maximum flow rate (Q-max)
Change of Maximum flow rate (Q-max)
Time frame: 12 months after surgery
Change of Maximum flow rate (Q-max)
Change of Maximum flow rate (Q-max)
Time frame: 24 months after surgery
Change of Maximum flow rate (Q-max)
Change of Maximum flow rate (Q-max)
Time frame: 36 months after surgery
Change of Maximum flow rate (Q-max)
Post-Void Residual (PVR) volume
Time frame: Baseline
Post-Void Residual (PVR) volume
Change of Post-Void Residual (PVR) volume
Time frame: 1 month after surgery
Change of Post-Void Residual (PVR) volume
Change of Post-Void Residual (PVR) volume
Time frame: 3 months after surgery
Change of Post-Void Residual (PVR) volume
Change of Post-Void Residual (PVR) volume
Time frame: 6 months after surgery
Change of Post-Void Residual (PVR) volume
Change of Post-Void Residual (PVR) volume
Time frame: 12 months after surgery
Change of Post-Void Residual (PVR) volume
Change of Post-Void Residual (PVR) volume
Time frame: 24 months after surgery
Change of Post-Void Residual (PVR) volume
Change of Post-Void Residual (PVR) volume
Time frame: 36 months after surgery
Change of Post-Void Residual (PVR) volume
Prostate Volume measured by transrectal ultrasound (TRUS)
Time frame: Baseline
Prostate Volume measured by transrectal ultrasound (TRUS)
Change of Prostate Volume measured by transrectal ultrasound (TRUS)
Time frame: 12 months after surgery
Change of Prostate Volume measured by transrectal ultrasound (TRUS)
Questionnaire
Time frame: Baseline
IPSS
Change of Questionnaire
Time frame: 1 month after surgery
Change of IPSS score
Change of Questionnaire
Time frame: 3 months after surgery
Change of IPSS score
Change of Questionnaire
Time frame: 6 months after surgery
Change of IPSS score
Change of Questionnaire
Time frame: 12 months after surgery
Change of IPSS score
Change of Questionnaire
Time frame: 24 months after surgery
Change of IPSS score
Change of Questionnaire
Time frame: 36 months after surgery
Change of IPSS score
Adverse Events
Time frame: Baseline
Adverse Events
Change of Adverse Events
Time frame: 1 month after surgery
Change of Adverse Events
Change of Adverse Events
Time frame: 3 months after surgery
Change of Adverse Events
Change of Adverse Events
Time frame: 6 months after surgery
Change of Adverse Events
Change of Adverse Events
Time frame: 12 months after surgery
Change of Adverse Events
Change of Adverse Events
Time frame: 24 months after surgery
Change of Adverse Events
Change of Adverse Events
Time frame: 36 months after surgery
Change of Adverse Events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dean Elterman principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urologic Diseases, run by Can-Am HIFU Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iris Chan (416-603-5800 ext. 5033, iris.chan2@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum flow rate (Q-max) (time frame: Baseline). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.