To demonstrate the safety and feasibility of the Mercury Expander system and procedure to treat patients with lower urinary tract symptoms (LUTS) secondary to urinary outflow obstruction from benign prostatic hyperplasia.
A prospective, non-randomized, two-arm, multi-center clinical trial designed to evaluate the safety and feasibility of the Mercury Expander system in patients with lower urinary tract symptoms (LUTS) secondary to urinary outflow obstruction from benign prostatic hyperplasia (BPH).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Implantation and retrieval of the XFLO Expander System in the prostatic urethra to treat benign prostatic hyperplasia (BPH)
Australian Clinical Trials Pty Ltd
Wahroonga, New South Wales, Australia
University Health Network
Toronto, Ontario, Canada
Brunswick Medical Center
Montreal, Canada
National Center of Urology
Tbilisi, Georgia
Freedom from Unanticipated adverse device effects (UADEs)
Measure any device or procedure related adverse events
Time frame: 1 month (Arm-1)
Freedom from Unanticipated adverse device effects (UADEs)
Measure any device or procedure related adverse events
Time frame: 6 months (Arm-2)
Freedom from Unanticipated adverse device effects (UADEs)
Measure any device or procedure related adverse events
Time frame: 7 months (Arm-1)
Freedom from Unanticipated adverse device effects (UADEs)
Measure any device or procedure related adverse events
Time frame: 12 months (Arm-2)
Change in International Prostate Symptom Score (IPSS)
Measure improvement in lower urinary tract symptoms related to benign prostatic hyperplasia (BPH)
Time frame: 1 month and 7 months (Arm-1)
Change in International Prostate Symptom Score (IPSS)
Measure improvement in lower urinary tract symptoms related to benign prostatic hyperplasia (BPH)
Time frame: 6 and 12 months (Arm-2)
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China Medical University Hospital
Taichung, Taiwan