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

Recruiting

• Conditions: Urologic Diseases

• Registration Number: NCT05201131
• Lead Sponsor: Can-Am HIFU Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-07
• Study First Submitted: 2021-11-27
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-07
• Last Update Submitted: 2022-01-07
• Study First Posted: 2022-01-21
• Last Update Posted: 2022-01-21
• Primary Completion: 2023-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum flow rate (Q-max)	Baseline	Maximum flow rate (Q-max)
Prostate Volume measured by transrectal ultrasound (TRUS)	Baseline	Prostate Volume measured by transrectal ultrasound (TRUS)
Questionnaire	Baseline	IPSS
Adverse Events	Baseline	Adverse Events
Change of Adverse Events	36 months after surgery	Change of Adverse Events
Change of Post-Void Residual (PVR) volume	36 months after surgery	Change of Post-Void Residual (PVR) volume
Change of Prostate Volume measured by transrectal ultrasound (TRUS)	12 months after surgery	Change of Prostate Volume measured by transrectal ultrasound (TRUS)
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 Questionnaire	36 months after surgery	Change of IPSS score

Trial Locations

Locations (1)

Dean Elterman; 🇨🇦 Toronto, Ontario, Canada