Actively Recruiting
Canadian Cohort of Aquablation, a Robotically Executed, Surgeon-guided, High-pressure Water Jet Ablation Therapy for Endoscopic Resection of Prostate Tissue in Benign Prostatic Hyperplasia (BPH)
Led by Can-Am HIFU Inc. · Updated on 2021-12-27
25
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Aquablation therapy, a robotically executed, surgeon-guided high-pressure water jet procedure, for men with benign prostatic hyperplasia (BPH) in a Canadian patient group. The goal is to document the clinical outcomes of this treatment for BPH, a condition involving prostate enlargement that affects urinary function. Patients will be followed as part of standard care for up to three years to gather data on the therapy's effects. The study focuses on Aquablation as the primary intervention, which involves endoscopic resection of prostate tissue using high-pressure water jets guided by robotic technology and a surgeon. There are no comparison groups mentioned, as this is an observational study documenting outcomes after Aquablation therapy. The treatment is delivered once, and patients are monitored over time to assess changes. Participants will be evaluated at multiple points including baseline, 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months after surgery. Assessments include maximum urine flow rate (Q-max), post-void residual (PVR) urine volume, prostate volume, patient questionnaires, and monitoring for adverse events. Follow-up visits align with routine care to track the therapy's impact and safety over three years.
CONDITIONS
Brief Title
Aquablation in Benign Prostatic Hyperplasia in Canada
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary diagnosis of Benign Prostate Hypertrophy (BPH)
- Male subjects of 65 18 years of age
- Candidate for Aquablation therapy as per clinical decision of Investigator
- Willing and able to accurately complete 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.
Duration - Day of surgery plus initial recovery period
Participants undergo Aquablation, a robotic water jet ablation procedure to remove prostate tissue, followed by immediate post-operative care.
1 surgery day visit and immediate post-operative care visits
Duration - Up to 3 years after surgery
Participants are monitored for safety and recovery with assessments including maximum flow rate, post-void residual volume, prostate volume, questionnaires, and adverse event reporting.
Visits at 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months after surgery
Trial Site Locations
Total: 1 location
1
Dean Elterman
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
Research Team
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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