Aquablation in Benign Prostatic Hyperplasia in Canada

Urologic Diseases Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05169892
• Other study ID #: Aquablation in BPH
• Status: Recruiting
• Start date: October 9, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2021
• Source: Can-Am HIFU Inc.
• Contact: Dean Elterman
• Phone: 4166035800
• Email: dean.elterman[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia
• Urologic Diseases

Intervention

Procedure:
• Aquablation
Aquablation

Locations

Country	Name	City	State
Canada	Dean Elterman	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Can-Am HIFU Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum flow rate (Q-max)	Standard of care	Baseline
Primary	Post-Void Residual (PVR) volume	Standard of care	Baseline
Primary	Maximum flow rate (Q-max)	Standard of care	1 month after surgery
Primary	Post-Void Residual (PVR) volume	Standard of care	1 month after surgery
Primary	Maximum flow rate (Q-max)	Standard of care	3 months after surgery
Primary	Post-Void Residual (PVR) volume	Standard of care	3 months after surgery
Primary	Maximum flow rate (Q-max)	Standard of care	6 months after surgery
Primary	Post-Void Residual (PVR) volume	Standard of care	6 months after surgery
Primary	Maximum flow rate (Q-max)	Standard of care	12 months after surgery
Primary	Post-Void Residual (PVR) volume	Standard of care	12 months after surgery
Primary	Maximum flow rate (Q-max)	Standard of care	24 months after surgery
Primary	Post-Void Residual (PVR) volume	Standard of care	24 months after surgery
Primary	Maximum flow rate (Q-max)	Standard of care	36 months after surgery
Primary	Post-Void Residual (PVR) volume	Standard of care	36 months after surgery
Primary	Prostate Volume	Standard of care	Baseline
Primary	Prostate Volume	Standard of care	12 months after surgery
Primary	Questionnaires	IPSS	Baseline
Primary	Questionnaires	IPSS	1 month after surgery
Primary	Questionnaires	IPSS	3 months after surgery
Primary	Questionnaires	IPSS	6 months after surgery
Primary	Questionnaires	IPSS	12 months after surgery
Primary	Questionnaires	IPSS	24 months after surgery
Primary	Questionnaires	IPSS	36 months after surgery
Primary	Adverse Events	Adverse Events	Baseline
Primary	Adverse Events	Adverse Events	1 day of Surgery
Primary	Adverse Events	Adverse Events	1 month after surgery
Primary	Adverse Events	Adverse Events	3 months after surgery
Primary	Adverse Events	Adverse Events	6 months after surgery
Primary	Adverse Events	Adverse Events	12 months after surgery
Primary	Adverse Events	Adverse Events	24 months after surgery
Primary	Adverse Events	Adverse Events	36 months after surgery