Aquablation in Benign Prostatic Hyperplasia in Canada
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 Aquablation therapy for BPH patient in Canadian cohort.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Primary diagnosis of Benign Prostate Hypertrophy (BPH)
Male subjects of ≥ 18 years of age
Candidate for Aquablation therapy as per clinical decision of Investigator
Willing and able to accurately complete 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
BPH patients treated by Aquablation
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Aquablation
Procedure/SurgeryAquablation
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Aquablation1 intervention
Trial outcomes
Primary outcomes
1
Maximum flow rate (Q-max)
Standard of care
Time frame
Baseline2
Post-Void Residual (PVR) volume
Standard of care
Time frame
Baseline3
Maximum flow rate (Q-max)
Standard of care
Time frame
1 month after surgery4
Post-Void Residual (PVR) volume
Standard of care
Time frame
1 month 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