Recruiting

Aquablation

Sponsor:

Can-Am HIFU Inc.

Code:

NCT05169892

Conditions

Urologic Diseases

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aquablation

Study Details

Brief summary:

To document the clinical outcome of Aquablation therapy for BPH patient in Canadian cohort.

Conditions

Urologic Diseases

Study ID

NCT05169892

Start date

Oct 9, 2019

Status verified date

Aug, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

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 Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

Aquablation

Interventions

Aquablation

Aquablation

Primary outcome measure

  • Maximum flow rate (Q-max) [ Time Frame: Baseline ]
  • Post-Void Residual (PVR) volume [ Time Frame: Baseline ]
  • Maximum flow rate (Q-max) [ Time Frame: 1 month after surgery ]
  • Post-Void Residual (PVR) volume [ Time Frame: 1 month after surgery ]
  • Maximum flow rate (Q-max) [ Time Frame: 3 months after surgery ]
  • Post-Void Residual (PVR) volume [ Time Frame: 3 months after surgery ]
  • Maximum flow rate (Q-max) [ Time Frame: 6 months after surgery ]
  • Post-Void Residual (PVR) volume [ Time Frame: 6 months after surgery ]
  • Maximum flow rate (Q-max) [ Time Frame: 12 months after surgery ]
  • Post-Void Residual (PVR) volume [ Time Frame: 12 months after surgery ]
  • Maximum flow rate (Q-max) [ Time Frame: 24 months after surgery ]
  • Post-Void Residual (PVR) volume [ Time Frame: 24 months after surgery ]
  • Maximum flow rate (Q-max) [ Time Frame: 36 months after surgery ]
  • Post-Void Residual (PVR) volume [ Time Frame: 36 months after surgery ]
  • Prostate Volume [ Time Frame: Baseline ]
  • Prostate Volume [ Time Frame: 12 months after surgery ]
  • Questionnaires [ Time Frame: Baseline ]
  • Questionnaires [ Time Frame: 1 month after surgery ]
  • Questionnaires [ Time Frame: 3 months after surgery ]
  • Questionnaires [ Time Frame: 6 months after surgery ]
  • Questionnaires [ Time Frame: 12 months after surgery ]
  • Questionnaires [ Time Frame: 24 months after surgery ]
  • Questionnaires [ Time Frame: 36 months after surgery ]
  • Adverse Events [ Time Frame: Baseline ]
  • Adverse Events [ Time Frame: 1 day of Surgery ]
  • Adverse Events [ Time Frame: 1 month after surgery ]
  • Adverse Events [ Time Frame: 3 months after surgery ]
  • Adverse Events [ Time Frame: 6 months after surgery ]
  • Adverse Events [ Time Frame: 12 months after surgery ]
  • Adverse Events [ Time Frame: 24 months after surgery ]
  • Adverse Events [ Time Frame: 36 months after surgery ]

Central Contacts and Locations

Central contacts

Iris Chan

4166035800iris.chan2@uhn.ca

Dean Chan

17787928125iris.chan2@uhn.ca

Locations

Dean Elterman

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Dean Elterman

4166035800dean.elterman@uhn.ca

Iris Chan

4166035800dean.elterman@uhn.ca

Principal Investigator:

Dean Elterman

More Information

Sponsor

Can-Am HIFU Inc.

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • benigh prostate hypertrophy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Can-Am HIFU Inc. on 2026-08-19.