Actively Recruiting
Canadian Cohort of Convective Thermal Therapy Using Rezum System in Benign Prostatic Hyperplasia (BPH)
Led by Can-Am HIFU Inc. · Updated on 2022-01-21
50
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are documenting the clinical outcomes of Rezum therapy for men diagnosed with benign prostatic hyperplasia (BPH) within a Canadian patient group. This observational study aims to understand how patients respond to this convective thermal treatment using the Rezum System and how it affects their urinary function and prostate health over time. The intervention involves the Rezum procedure, which is a thermal therapy designed to treat BPH. Participants receive the Rezum treatment, and their progress is monitored at multiple intervals after the procedure to assess changes in urinary flow, prostate size, and symptoms. Follow-up measurements occur at baseline and then at 1, 3, 6, 12, 24, and 36 months after surgery to track the therapy's effects over an extended period. Participants will undergo various assessments including maximum urinary flow rate, post-void residual urine volume, prostate volume by ultrasound, and symptom questionnaires. Adverse events are also recorded at each time point to monitor safety. The study involves long-term follow-up for up to three years after treatment to gather comprehensive data on patient outcomes and therapy impact.
CONDITIONS
Brief Title
Canadian Cohort of Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects of 63; 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
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo the Rezum procedure for treatment of Benign Prostatic Hyperplasia (BPH).
1 procedure visit (in-person)
Duration - Up to 36 months
Participants are followed up to monitor their recovery and changes in symptoms after the Rezum procedure.
Visits at 1, 3, 6, 12, 24, and 36 months after surgery
Trial Site Locations
Total: 1 location
1
Dean Elterman
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
Research Team
I
Iris Chan
D
Dean Elterman
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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