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

Urologic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05201131
• Other study ID #: Rezum in BPH CAN
• Status: Recruiting
• Start date: October 7, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2022
• Source: Can-Am HIFU Inc.
• Contact: Iris Chan
• Phone: 416-603-5800
• Email: iris.chan2[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male subjects of = 18 years of age.
• Primary diagnosis of Benign Prostate Hypertrophy (BPH).
• Candidate for Rezum 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.

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia
• Urologic Diseases

Intervention

Procedure:
• Rezum
Rezum

Locations

Country	Name	City	State
Canada	Dean Elterman	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Can-Am HIFU Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum flow rate (Q-max)	Maximum flow rate (Q-max)	Baseline
Primary	Change of Maximum flow rate (Q-max)	Change of Maximum flow rate (Q-max)	1 month after surgery
Primary	Change of Maximum flow rate (Q-max)	Change of Maximum flow rate (Q-max)	3 months after surgery
Primary	Change of Maximum flow rate (Q-max)	Change of Maximum flow rate (Q-max)	6 months after surgery
Primary	Change of Maximum flow rate (Q-max)	Change of Maximum flow rate (Q-max)	12 months after surgery
Primary	Change of Maximum flow rate (Q-max)	Change of Maximum flow rate (Q-max)	24 months after surgery
Primary	Change of Maximum flow rate (Q-max)	Change of Maximum flow rate (Q-max)	36 months after surgery
Primary	Post-Void Residual (PVR) volume	Post-Void Residual (PVR) volume	Baseline
Primary	Change of Post-Void Residual (PVR) volume	Change of Post-Void Residual (PVR) volume	1 month after surgery
Primary	Change of Post-Void Residual (PVR) volume	Change of Post-Void Residual (PVR) volume	3 months after surgery
Primary	Change of Post-Void Residual (PVR) volume	Change of Post-Void Residual (PVR) volume	6 months after surgery
Primary	Change of Post-Void Residual (PVR) volume	Change of Post-Void Residual (PVR) volume	12 months after surgery
Primary	Change of Post-Void Residual (PVR) volume	Change of Post-Void Residual (PVR) volume	24 months after surgery
Primary	Change of Post-Void Residual (PVR) volume	Change of Post-Void Residual (PVR) volume	36 months after surgery
Primary	Prostate Volume measured by transrectal ultrasound (TRUS)	Prostate Volume measured by transrectal ultrasound (TRUS)	Baseline
Primary	Change of Prostate Volume measured by transrectal ultrasound (TRUS)	Change of Prostate Volume measured by transrectal ultrasound (TRUS)	12 months after surgery
Primary	Questionnaire	IPSS	Baseline
Primary	Change of Questionnaire	Change of IPSS score	1 month after surgery
Primary	Change of Questionnaire	Change of IPSS score	3 months after surgery
Primary	Change of Questionnaire	Change of IPSS score	6 months after surgery
Primary	Change of Questionnaire	Change of IPSS score	12 months after surgery
Primary	Change of Questionnaire	Change of IPSS score	24 months after surgery
Primary	Change of Questionnaire	Change of IPSS score	36 months after surgery
Primary	Adverse Events	Adverse Events	Baseline
Primary	Change of Adverse Events	Change of Adverse Events	1 month after surgery
Primary	Change of Adverse Events	Change of Adverse Events	3 months after surgery
Primary	Change of Adverse Events	Change of Adverse Events	6 months after surgery
Primary	Change of Adverse Events	Change of Adverse Events	12 months after surgery
Primary	Change of Adverse Events	Change of Adverse Events	24 months after surgery
Primary	Change of Adverse Events	Change of Adverse Events	36 months after surgery