| Registry | NCT05201131 |
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| Status | Recruiting |
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| Study type | Observational |
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| Enrollment | 50 (Estimated) |
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| Sponsor | Can-Am HIFU Inc. (Other) |
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| Conditions | Urologic Diseases |
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| Interventions | Rezum (Procedure) |
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| Dates | start 2019-10-07, primary completion 2028-12-31 (estimated), completion 2029-12-31 (estimated), first posted 2022-01-21, last updated 2026-08-19 |
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| Locations | 1 site in Canada |
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Related Papers Related Patents Related Grants Related Experts
All trials for Urologic Diseases All trials of Rezum
-Summary
To document the clinical outcome of Rezūm therapy for BPH patient in Canadian cohort.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Rezum procedure | | Procedure: Rezum | |
+Outcome measures
Primary outcomes
- Maximum flow rate (Q-max) [Baseline]: Maximum flow rate (Q-max)
- Change of Maximum flow rate (Q-max) [1 month after surgery]: Change of Maximum flow rate (Q-max)
- Change of Maximum flow rate (Q-max) [3 months after surgery]: Change of Maximum flow rate (Q-max)
- Change of Maximum flow rate (Q-max) [6 months after surgery]: Change of Maximum flow rate (Q-max)
- Change of Maximum flow rate (Q-max) [12 months after surgery]: Change of Maximum flow rate (Q-max)
- Change of Maximum flow rate (Q-max) [24 months after surgery]: Change of Maximum flow rate (Q-max)
- Change of Maximum flow rate (Q-max) [36 months after surgery]: Change of Maximum flow rate (Q-max)
- Post-Void Residual (PVR) volume [Baseline]: Post-Void Residual (PVR) volume
- Change of Post-Void Residual (PVR) volume [1 month after surgery]: Change of Post-Void Residual (PVR) volume
- Change of Post-Void Residual (PVR) volume [3 months after surgery]: Change of Post-Void Residual (PVR) volume
- Change of Post-Void Residual (PVR) volume [6 months after surgery]: Change of Post-Void Residual (PVR) volume
- Change of Post-Void Residual (PVR) volume [12 months after surgery]: Change of Post-Void Residual (PVR) volume
- Change of Post-Void Residual (PVR) volume [24 months after surgery]: Change of Post-Void Residual (PVR) volume
- Change of Post-Void Residual (PVR) volume [36 months after surgery]: Change of Post-Void Residual (PVR) volume
- Prostate Volume measured by transrectal ultrasound (TRUS) [Baseline]: Prostate Volume measured by transrectal ultrasound (TRUS)
- Change of Prostate Volume measured by transrectal ultrasound (TRUS) [12 months after surgery]: Change of Prostate Volume measured by transrectal ultrasound (TRUS)
- Questionnaire [Baseline]: IPSS
- Change of Questionnaire [1 month after surgery]: Change of IPSS score
- Change of Questionnaire [3 months after surgery]: Change of IPSS score
- Change of Questionnaire [6 months after surgery]: Change of IPSS score
- Change of Questionnaire [12 months after surgery]: Change of IPSS score
- Change of Questionnaire [24 months after surgery]: Change of IPSS score
- Change of Questionnaire [36 months after surgery]: Change of IPSS score
- Adverse Events [Baseline]: Adverse Events
- Change of Adverse Events [1 month after surgery]: Change of Adverse Events
- Change of Adverse Events [3 months after surgery]: Change of Adverse Events
- Change of Adverse Events [6 months after surgery]: Change of Adverse Events
- Change of Adverse Events [12 months after surgery]: Change of Adverse Events
- Change of Adverse Events [24 months after surgery]: Change of Adverse Events
- Change of Adverse Events [36 months after surgery]: Change of Adverse Events
+Eligibility
Sex: Male, ages: 18 Years to any
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.
+Locations (1)
| Facility | City | Country | Status |
|---|
| Dean Elterman | Toronto, Ontario | Canada | Recruiting |
+Investigators
- Dean Elterman, Principal investigator, University Health Network, Toronto