Aquablation in Benign Prostatic Hyperplasia in Canada

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).

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

Study Overview

• Status: Recruiting
• Conditions: Urologic Diseases
• Intervention / Treatment: Procedure: Aquablation

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

• Study Contact: Name: Dean Elterman; Phone Number: 5033 4166035800; Email: dean.elterman@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Recruiting
      • Dean Elterman
      • Contact: Dean Elterman; Phone Number: 5033 4166035800; Email: dean.elterman@uhn.ca
      • Contact: Iris Chan; Phone Number: Elterman 4166035800; Email: dean.elterman@uhn.ca
      • Principal Investigator: Dean Elterman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

BPH patients treated by Aquablation

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aquablation	Procedure: Aquablation; Aquablation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Can-Am HIFU Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: November 27, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 27, 2021

Study Record Updates

• Last Update Posted (Actual): December 27, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: benigh prostate hypertrophy
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Urologic Diseases
• Other Study ID Numbers: Aquablation in BPH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No