Actively Recruiting
Aquablation Therapy for Benign Prostate Enlargement in Canadian Men A Study to Track Outcomes Over Three Years
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 therapys 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 therapys 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
Research Team
D
Dean Elterman
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