Clinical trial NCT05169892: Aquablation in Benign Prostatic Hyperplasia in Canada
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).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urologic Diseases
Keywords: benigh prostate hypertrophy
Lead sponsor: Can-Am HIFU Inc.
Sponsor class: OTHER
First posted: 2021-12-27
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: BPH patients treated by Aquablation

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum flow rate (Q-max)
timeFrame: Baseline
measure: Post-Void Residual (PVR) volume
timeFrame: Baseline
measure: Maximum flow rate (Q-max)
timeFrame: 1 month after surgery
measure: Post-Void Residual (PVR) volume
timeFrame: 1 month after surgery
measure: Maximum flow rate (Q-max)
timeFrame: 3 months after surgery
measure: Post-Void Residual (PVR) volume
timeFrame: 3 months after surgery
measure: Maximum flow rate (Q-max)
timeFrame: 6 months after surgery
measure: Post-Void Residual (PVR) volume
timeFrame: 6 months after surgery
measure: Maximum flow rate (Q-max)
timeFrame: 12 months after surgery
measure: Post-Void Residual (PVR) volume
timeFrame: 12 months after surgery
measure: Maximum flow rate (Q-max)
timeFrame: 24 months after surgery
measure: Post-Void Residual (PVR) volume
timeFrame: 24 months after surgery
measure: Maximum flow rate (Q-max)
timeFrame: 36 months after surgery
measure: Post-Void Residual (PVR) volume
timeFrame: 36 months after surgery
measure: Prostate Volume
timeFrame: Baseline
measure: Prostate Volume
timeFrame: 12 months after surgery
measure: Questionnaires
timeFrame: Baseline
measure: Questionnaires
timeFrame: 1 month after surgery
measure: Questionnaires
timeFrame: 3 months after surgery
measure: Questionnaires
timeFrame: 6 months after surgery
measure: Questionnaires
timeFrame: 12 months after surgery
measure: Questionnaires
timeFrame: 24 months after surgery
measure: Questionnaires
timeFrame: 36 months after surgery
measure: Adverse Events
timeFrame: Baseline
measure: Adverse Events
timeFrame: 1 day of Surgery
measure: Adverse Events
timeFrame: 1 month after surgery
measure: Adverse Events
timeFrame: 3 months after surgery
measure: Adverse Events
timeFrame: 6 months after surgery
measure: Adverse Events
timeFrame: 12 months after surgery
measure: Adverse Events
timeFrame: 24 months after surgery
measure: Adverse Events
timeFrame: 36 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Dean Elterman
state: Ontario
Study officials:
References: