Status:
RECRUITING
AQUABEAM® Robotic System and Ultrasound Accessories
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
PROCEPT BioRobotics
Conditions:
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Lower urinary symptoms (LUTS) affect many older men and their frequency and severity increase with age. In the age group between 65 and 79 years the rate of men with moderate and severe LUTS is 20 - 2...
Detailed Description
A- Background: Lower urinary symptoms (LUTS) affect many older men and their frequency and severity increase with age. In the age group between 65 and 79 years the rate of men with moderate and sever...
Eligibility Criteria
Inclusion Criteria:
- a) Patient has diagnosis of LUTS due to BPH
- b) Patient is mentally capable and willing to sign a study-specific informed consent form
- c) Patient is able and willing to follow study instructions and likely to attend and complete all required study visits
Exclusion Criteria:
- a) Patient is unable to stop anticoagulants, antiplatelet agents, or non-steroidal anti- inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior to treatment per standard of care
- b) Contraindications for general and spinal anesthesia
- c) Patient is unwilling to accept a blood transfusion if required
Key Trial Info
Start Date :
February 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05157529
Start Date
February 16 2023
End Date
December 30 2024
Last Update
June 7 2024
Active Locations (1)
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1
Centre Hospitalier de l'université de Montréal (CHUM)
Montreal, Quebec, Canada, QC H2X 0A9