Recruiting

Rezūm System

Sponsor:

Can-Am HIFU Inc.

Code:

NCT05201131

Conditions

Urologic Diseases

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rezum

Study Details

Brief summary:

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

Conditions

Urologic Diseases

Study ID

NCT05201131

Start date

Oct 7, 2019

Status verified date

Aug, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Rezum procedure

Interventions

Rezum

Rezum

Primary outcome measure

  • Maximum flow rate (Q-max) [ Time Frame: Baseline ]
  • Change of Maximum flow rate (Q-max) [ Time Frame: 1 month after surgery ]
  • Change of Maximum flow rate (Q-max) [ Time Frame: 3 months after surgery ]
  • Change of Maximum flow rate (Q-max) [ Time Frame: 6 months after surgery ]
  • Change of Maximum flow rate (Q-max) [ Time Frame: 12 months after surgery ]
  • Change of Maximum flow rate (Q-max) [ Time Frame: 24 months after surgery ]
  • Change of Maximum flow rate (Q-max) [ Time Frame: 36 months after surgery ]
  • Post-Void Residual (PVR) volume [ Time Frame: Baseline ]
  • Change of Post-Void Residual (PVR) volume [ Time Frame: 1 month after surgery ]
  • Change of Post-Void Residual (PVR) volume [ Time Frame: 3 months after surgery ]
  • Change of Post-Void Residual (PVR) volume [ Time Frame: 6 months after surgery ]
  • Change of Post-Void Residual (PVR) volume [ Time Frame: 12 months after surgery ]
  • Change of Post-Void Residual (PVR) volume [ Time Frame: 24 months after surgery ]
  • Change of Post-Void Residual (PVR) volume [ Time Frame: 36 months after surgery ]
  • Prostate Volume measured by transrectal ultrasound (TRUS) [ Time Frame: Baseline ]
  • Change of Prostate Volume measured by transrectal ultrasound (TRUS) [ Time Frame: 12 months after surgery ]
  • Questionnaire [ Time Frame: Baseline ]
  • Change of Questionnaire [ Time Frame: 1 month after surgery ]
  • Change of Questionnaire [ Time Frame: 3 months after surgery ]
  • Change of Questionnaire [ Time Frame: 6 months after surgery ]
  • Change of Questionnaire [ Time Frame: 12 months after surgery ]
  • Change of Questionnaire [ Time Frame: 24 months after surgery ]
  • Change of Questionnaire [ Time Frame: 36 months after surgery ]
  • Adverse Events [ Time Frame: Baseline ]
  • Change of Adverse Events [ Time Frame: 1 month after surgery ]
  • Change of Adverse Events [ Time Frame: 3 months after surgery ]
  • Change of Adverse Events [ Time Frame: 6 months after surgery ]
  • Change of Adverse Events [ Time Frame: 12 months after surgery ]
  • Change of Adverse Events [ Time Frame: 24 months after surgery ]
  • Change of Adverse Events [ Time Frame: 36 months after surgery ]

Central Contacts and Locations

Central contacts

Iris Chan

416-603-5800iris.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.