Canadian Cohort of Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH).
ConditionUrologic Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorCan-Am HIFU Inc.
About this trial
To document the clinical outcome of Rezūm therapy for BPH patient in Canadian cohort.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
* Male subjects of ≥ 18 years of age. * Primary diagnosis of Benign Prostate Hypertrophy (BPH). * Candidate for or have already completed Rezūm therapy as per clinical decision of Investigator.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Rezum
Procedure/SurgeryRezum
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Rezum procedure1 intervention
Trial outcomes
Primary outcomes
1
Maximum flow rate (Q-max)
Maximum flow rate (Q-max)
Time frame
Baseline2
Change of Maximum flow rate (Q-max)
Change of Maximum flow rate (Q-max)
Time frame
1 month after surgery3
Change of Maximum flow rate (Q-max)
Change of Maximum flow rate (Q-max)
Time frame
3 months after surgery4
Change of Maximum flow rate (Q-max)
Change of Maximum flow rate (Q-max)
Time frame
6 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Can-Am HIFU Inc.
Lead sponsor
University Health Network, Toronto
Sponsor institution
Source ClinicalTrials.gov