Canadian Cohort of Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH).

August 17, 2026 updated by: Dean Elterman, Can-Am HIFU Inc.
To document the clinical outcome of Rezūm therapy for BPH patient in Canadian cohort.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Dean Elterman
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dean Elterman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Rezum procedure
Procedure: Rezum
Rezum

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum flow rate (Q-max)
Time Frame: Baseline
Maximum flow rate (Q-max)
Baseline
Change of Maximum flow rate (Q-max)
Time Frame: 1 month after surgery
Change of Maximum flow rate (Q-max)
1 month after surgery
Change of Maximum flow rate (Q-max)
Time Frame: 3 months after surgery
Change of Maximum flow rate (Q-max)
3 months after surgery
Change of Maximum flow rate (Q-max)
Time Frame: 6 months after surgery
Change of Maximum flow rate (Q-max)
6 months after surgery
Change of Maximum flow rate (Q-max)
Time Frame: 12 months after surgery
Change of Maximum flow rate (Q-max)
12 months after surgery
Change of Maximum flow rate (Q-max)
Time Frame: 24 months after surgery
Change of Maximum flow rate (Q-max)
24 months after surgery
Change of Maximum flow rate (Q-max)
Time Frame: 36 months after surgery
Change of Maximum flow rate (Q-max)
36 months after surgery
Post-Void Residual (PVR) volume
Time Frame: Baseline
Post-Void Residual (PVR) volume
Baseline
Change of Post-Void Residual (PVR) volume
Time Frame: 1 month after surgery
Change of Post-Void Residual (PVR) volume
1 month after surgery
Change of Post-Void Residual (PVR) volume
Time Frame: 3 months after surgery
Change of Post-Void Residual (PVR) volume
3 months after surgery
Change of Post-Void Residual (PVR) volume
Time Frame: 6 months after surgery
Change of Post-Void Residual (PVR) volume
6 months after surgery
Change of Post-Void Residual (PVR) volume
Time Frame: 12 months after surgery
Change of Post-Void Residual (PVR) volume
12 months after surgery
Change of Post-Void Residual (PVR) volume
Time Frame: 24 months after surgery
Change of Post-Void Residual (PVR) volume
24 months after surgery
Change of Post-Void Residual (PVR) volume
Time Frame: 36 months after surgery
Change of Post-Void Residual (PVR) volume
36 months after surgery
Prostate Volume measured by transrectal ultrasound (TRUS)
Time Frame: Baseline
Prostate Volume measured by transrectal ultrasound (TRUS)
Baseline
Change of Prostate Volume measured by transrectal ultrasound (TRUS)
Time Frame: 12 months after surgery
Change of Prostate Volume measured by transrectal ultrasound (TRUS)
12 months after surgery
Questionnaire
Time Frame: Baseline
IPSS
Baseline
Change of Questionnaire
Time Frame: 1 month after surgery
Change of IPSS score
1 month after surgery
Change of Questionnaire
Time Frame: 3 months after surgery
Change of IPSS score
3 months after surgery
Change of Questionnaire
Time Frame: 6 months after surgery
Change of IPSS score
6 months after surgery
Change of Questionnaire
Time Frame: 12 months after surgery
Change of IPSS score
12 months after surgery
Change of Questionnaire
Time Frame: 24 months after surgery
Change of IPSS score
24 months after surgery
Change of Questionnaire
Time Frame: 36 months after surgery
Change of IPSS score
36 months after surgery
Adverse Events
Time Frame: Baseline
Adverse Events
Baseline
Change of Adverse Events
Time Frame: 1 month after surgery
Change of Adverse Events
1 month after surgery
Change of Adverse Events
Time Frame: 3 months after surgery
Change of Adverse Events
3 months after surgery
Change of Adverse Events
Time Frame: 6 months after surgery
Change of Adverse Events
6 months after surgery
Change of Adverse Events
Time Frame: 12 months after surgery
Change of Adverse Events
12 months after surgery
Change of Adverse Events
Time Frame: 24 months after surgery
Change of Adverse Events
24 months after surgery
Change of Adverse Events
Time Frame: 36 months after surgery
Change of Adverse Events
36 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Can-Am HIFU Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dean Elterman, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Rezum in BPH CAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings