Using Rezūm therapy for treating benign prostate enlargement in Canadian men
Canadian Cohort of Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH).
This study is testing how well Rezūm therapy works for Canadian men with benign prostate enlargement and how satisfied they are with the treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Can-Am HIFU Inc. Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05201131 on ClinicalTrials.gov |
What this trial studies
This observational study aims to document the clinical outcomes of the Rezūm therapy for patients diagnosed with benign prostatic hyperplasia (BPH) within a Canadian cohort. Male subjects aged 18 and older who are candidates for Rezūm therapy will be monitored for their responses to the treatment. The study will involve collecting data through questionnaires to assess the effectiveness and patient satisfaction with the therapy. The findings will contribute to understanding the therapy's impact on BPH management in Canada.
Who should consider this trial
Good fit: Ideal candidates for this study are male patients aged 18 and older with a primary diagnosis of benign prostatic hyperplasia who are deemed suitable for Rezūm therapy.
Not a fit: Patients with health conditions that make them unsuitable for the study or those unable to comply with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Rezūm therapy for managing benign prostatic hyperplasia, potentially improving patient care.
How similar studies have performed: While this study focuses on a specific Canadian cohort, similar approaches using Rezūm therapy have shown promise in other populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Toronto, Ontario
- Dean Elterman — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Dean Elterman — University Health Network, Toronto
- Study coordinator: Iris Chan
- Email: iris.chan2@uhn.ca
- Phone: 416-603-5800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.