The purpose of the study is to assess safety and efficacy of a novel steerable ureteral catheter system, the CVAC System for the treatment of urinary stones.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).
Muljibhai Patel Urological Hospital
Nadiād, India
Stone Clearance (% Reduction in Stone Volume)
The percent reduction (\[Baseline stone volume- 30-Day stone volume\] / Baseline stone volume) in stone volume following intervention, observed on non-contrast CT (NCCT) (2.0mm slice thickness). 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
Residual Stone Volume (RSV)
A continuous quantitative measure of remaining stone volume following intervention, observed on non-contrast CT (NCCT) (2.0mm slice thickness).
Time frame: 30 Days
Stone Free Rate (SFR) - Zero Fragments
Where stone free status is defined as zero residual fragments at 30 days observed on non-contrast CT (NCCT) (2.0mm slice thickness). SFR is calculated by determining the number of kidneys in each treatment arm with a stone free status of zero fragments and dividing that by the total number of kidneys treated in the respective treatment arm.
Time frame: 30 Days
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