The purpose of the study is to compare the effects, good and/or bad, of a treatment for removing kidney stones called the SURE procedure for stone evacuation to the standard treatment using a basket for stone removal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
The SURE stone evacuation procedure is a technique intended to more easily and completely remove a kidney stone during a kidney stone treatment. The urologist first uses a laser to break the kidney stone into small pieces. Then with the SURE procedure, the pieces are gently vacuumed out of the kidney instead of retrieving the pieces one-by-one with a basket or leaving them to pass naturally in the urine. Basketing is allowed and might be used with the SURE procedure, if needed to remove some small stones.
This is a treatment in which the urologist uses a laser to break a kidney stone into small pieces and then uses a tool called a basket to retrieve the pieces one at a time.
Mayo Clinic
Phoenix, Arizona, United States
Arizona Institute of Urology
Tucson, Arizona, United States
Johns Hopkins
Baltimore, Maryland, United States
Stone Free Rate (SFR) - Zero Fragments
The primary efficacy endpoint is the SFR, where stone free status is defined as zero residual fragments at 30 days observed on non-contrast CT (NCCT) (1.25mm slice thickness) by blinded central reviewer(s). The SFR is calculated by determining the number of subjects in each treatment arm with a stone free status of zero fragments and dividing that by the total number of subjects treated in the respective treatment arm.
Time frame: 30 Days
Residual Stone Volume (RSV)
A continuous quantitative measure of remaining stone volume following intervention, assessed via post-procedural imaging on NCCT (1.25mm slice thickness) by blinded central reviewer(s).
Time frame: 30 Days
Stone Clearance (% Reduction in Stone Volume)
Percent reduction (\[Baseline stone volume- 30-Day stone volume\] / Baseline stone volume) in stone volume following intervention, assessed via post-procedural imaging on NCCT (1.25mm slice thickness) by blinded central reviewer(s). A positive result indicates a decrease in stone volume removed during the procedure; a negative value indicates an increase in stone volume following the procedure.
Time frame: 30 Days
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New Jersey Urology
Voorhees Township, New Jersey, United States
Albany Medical College
Albany, New York, United States
Duke University
Durham, North Carolina, United States
Prisma Health
Greenville, South Carolina, United States
Urology Austin
Austin, Texas, United States
Dell Medical School, The University of Texas at Austin
Austin, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
...and 1 more locations