Aquablation in Benign Prostatic Hyperplasia in Canada

Recruiting

• Conditions: Urologic Diseases
• Interventions: Procedure: Aquablation

• Registration Number: NCT05169892
• Lead Sponsor: Can-Am HIFU Inc.

Brief Summary

To document the clinical outcome of Aquablation therapy for BPH patient in Canadian cohort.

Detailed Description

Patients will be followed up for 3 years as standard of care.

Study Timeline

• Study Start: 2019-10-09
• Study First Submitted: 2021-11-27
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-09
• Last Update Submitted: 2021-12-09
• Study First Posted: 2021-12-27
• Last Update Posted: 2021-12-27
• Primary Completion: 2023-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

• 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
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aquablation	Aquablation	-

Primary Outcome Measures

Name	Time	Method
Maximum flow rate (Q-max)	36 months after surgery	Standard of care
Post-Void Residual (PVR) volume	36 months after surgery	Standard of care
Questionnaires	36 months after surgery	IPSS
Adverse Events	36 months after surgery	Adverse Events
Prostate Volume	12 months after surgery	Standard of care

Trial Locations

Locations (1)

Dean Elterman; 🇨🇦 Toronto, Ontario, Canada