Urologic DiseasesNCT05169892
Aquablation in Benign Prostatic Hyperplasia in Canada
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 Aquablation 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?
- Aquablation
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 9 Oct 2019to 31 Dec 2030
- 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: BPH patients treated by Aquablation
Who may be able to join
- Primary diagnosis of Benign Prostate Hypertrophy (BPH)
- Male subjects of ≥ 18 years of age
- Candidate for Aquablation therapy as per clinical decision of Investigator
- Willing and able to accurately complete 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
Official title: Canadian Cohort of Aquablation, a Robotically Executed, Surgeon-guided, High-pressure Water Jet Ablation Therapy for Endoscopic Resection of Prostate Tissue, in Benign Prostatic Hyperplasia (BPH).
To document the clinical outcome of Aquablation therapy for BPH patient in Canadian cohort.
Read the detailed description
Patients will be followed up for 3 years as standard of care.
- Conditions
- Urologic Diseases
- Being tested
- Aquablation
- 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.
AquablationProcedure or surgery
Aquablation
| Study group | Role | What they receive |
|---|---|---|
| Aquablation | Not described Receives: Procedure: Aquablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum flow rate (Q-max)
Standard of care
Measured: Baseline
Post-Void Residual (PVR) volume
Standard of care
Measured: Baseline
Maximum flow rate (Q-max)
Standard of care
Measured: 1 month after surgery
Post-Void Residual (PVR) volume
Standard of care
Measured: 1 month after surgery
Maximum flow rate (Q-max)
Standard of care
Measured: 3 months after surgery
Post-Void Residual (PVR) volume
Standard of care
Measured: 3 months after surgery
Maximum flow rate (Q-max)
Standard of care
Measured: 6 months after surgery
Post-Void Residual (PVR) volume
Standard of care
Measured: 6 months after surgery
Maximum flow rate (Q-max)
Standard of care
Measured: 12 months after surgery
Post-Void Residual (PVR) volume
Standard of care
Measured: 12 months after surgery
Maximum flow rate (Q-max)
Standard of care
Measured: 24 months after surgery
Post-Void Residual (PVR) volume
Standard of care
Measured: 24 months after surgery
Maximum flow rate (Q-max)
Standard of care
Measured: 36 months after surgery
Post-Void Residual (PVR) volume
Standard of care
Measured: 36 months after surgery
Prostate Volume
Standard of care
Measured: Baseline
Prostate Volume
Standard of care
Measured: 12 months after surgery
Questionnaires
IPSS
Measured: Baseline
Questionnaires
IPSS
Measured: 1 month after surgery
Questionnaires
IPSS
Measured: 3 months after surgery
Questionnaires
IPSS
Measured: 6 months after surgery
Questionnaires
IPSS
Measured: 12 months after surgery
Questionnaires
IPSS
Measured: 24 months after surgery
Questionnaires
IPSS
Measured: 36 months after surgery
Adverse Events
Adverse Events
Measured: Baseline
Adverse Events
Adverse Events
Measured: 1 day of Surgery
Adverse Events
Adverse Events
Measured: 1 month after surgery
Adverse Events
Adverse Events
Measured: 3 months after surgery
Adverse Events
Adverse Events
Measured: 6 months after surgery
Adverse Events
Adverse Events
Measured: 12 months after surgery
Adverse Events
Adverse Events
Measured: 24 months after surgery
Adverse Events
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 posted27 Dec 2021
- Study start9 Oct 2019
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (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
- 25 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, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169892
- Sponsor's protocol ID
- Aquablation in BPH
- 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
- No
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 Aquablation, a Robotically Executed, Surgeon-guided, High-pressure Water Jet Ablation Therapy for Endoscopic Resection of Prostate Tissue, in Benign Prostatic Hyperplasia (BPH).
- ClinicalTrials.gov ID
- NCT05169892
- Acronym / sponsor ID
- Aquablation in BPH
- Conditions
- Urologic Diseases
- Keywords
- benigh prostate hypertrophy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Can-Am HIFU Inc.University, hospital or other
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Dec 2021 (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 Aquablation therapy for BPH patient in Canadian cohort.
Detailed description
Patients will be followed up for 3 years as standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aquablation | – | Procedure: Aquablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- BPH patients treated by Aquablation
Key inclusion criteria (5 listed)
- Primary diagnosis of Benign Prostate Hypertrophy (BPH)
- Male subjects of ≥ 18 years of age
- Candidate for Aquablation therapy as per clinical decision of Investigator
- Willing and able to accurately complete 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 |
|---|---|---|
| AquablationAquablation | Procedure or surgery | Aquablation |
Primary outcome
Maximum flow rate (Q-max)
Time frame: Baseline
Standard of care
Post-Void Residual (PVR) volume
Time frame: Baseline
Standard of care
Maximum flow rate (Q-max)
Time frame: 1 month after surgery
Standard of care
Post-Void Residual (PVR) volume
Time frame: 1 month after surgery
Standard of care
Maximum flow rate (Q-max)
Time frame: 3 months after surgery
Standard of care
Post-Void Residual (PVR) volume
Time frame: 3 months after surgery
Standard of care
Maximum flow rate (Q-max)
Time frame: 6 months after surgery
Standard of care
Post-Void Residual (PVR) volume
Time frame: 6 months after surgery
Standard of care
Maximum flow rate (Q-max)
Time frame: 12 months after surgery
Standard of care
Post-Void Residual (PVR) volume
Time frame: 12 months after surgery
Standard of care
Maximum flow rate (Q-max)
Time frame: 24 months after surgery
Standard of care
Post-Void Residual (PVR) volume
Time frame: 24 months after surgery
Standard of care
Maximum flow rate (Q-max)
Time frame: 36 months after surgery
Standard of care
Post-Void Residual (PVR) volume
Time frame: 36 months after surgery
Standard of care
Prostate Volume
Time frame: Baseline
Standard of care
Prostate Volume
Time frame: 12 months after surgery
Standard of care
Questionnaires
Time frame: Baseline
IPSS
Questionnaires
Time frame: 1 month after surgery
IPSS
Questionnaires
Time frame: 3 months after surgery
IPSS
Questionnaires
Time frame: 6 months after surgery
IPSS
Questionnaires
Time frame: 12 months after surgery
IPSS
Questionnaires
Time frame: 24 months after surgery
IPSS
Questionnaires
Time frame: 36 months after surgery
IPSS
Adverse Events
Time frame: Baseline
Adverse Events
Adverse Events
Time frame: 1 day of Surgery
Adverse Events
Adverse Events
Time frame: 1 month after surgery
Adverse Events
Adverse Events
Time frame: 3 months after surgery
Adverse Events
Adverse Events
Time frame: 6 months after surgery
Adverse Events
Adverse Events
Time frame: 12 months after surgery
Adverse Events
Adverse Events
Time frame: 24 months after surgery
Adverse Events
Adverse Events
Time frame: 36 months after surgery
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: No
Related trials for Urologic Diseases
RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease
RecruitingObservational study
Study of Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Recruiting
Diuretic Tuner Clinical Decision Support
Edema, Hypervolemia
RecruitingObservational study
En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
Bladder Cancer
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, MD 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 (4166035800 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 31 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.