Trial Outcomes & Findings for CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones (NCT NCT06615713)
NCT ID: NCT06615713
Last Updated: 2026-04-28
Results Overview
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.
COMPLETED
NA
30 participants
30 Days
2026-04-28
Participant Flow
Unit of analysis: kidneys
Participant milestones
| Measure |
Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System
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).
Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System: 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).
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Overall Study
STARTED
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30 32
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Overall Study
COMPLETED
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26 28
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Overall Study
NOT COMPLETED
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4 4
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones
Baseline characteristics by cohort
| Measure |
Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System
n=32 kidneys
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).
Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System: 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).
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Age, Continuous
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48 years
STANDARD_DEVIATION 16.2 • n=30 Participants
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Sex: Female, Male
Female
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10 Participants
n=30 Participants
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Sex: Female, Male
Male
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20 Participants
n=30 Participants
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Region of Enrollment
India
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30 participants
n=30 Participants
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Stone Density
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1203 HU
STANDARD_DEVIATION 345 • n=32 kidneys
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Total Stone Volume
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703.6 mm^3
STANDARD_DEVIATION 835.4 • n=32 kidneys
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PRIMARY outcome
Timeframe: 30 DaysPopulation: All kidneys available at follow-up were analyzed.
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.
Outcome measures
| Measure |
Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System
n=28 kidneys
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).
Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System: 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).
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Stone Clearance (% Reduction in Stone Volume)
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96.2 % stone volume removed
Standard Deviation 6.5
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PRIMARY outcome
Timeframe: 30 DaysPopulation: All kidneys available at follow-up were analyzed.
A continuous quantitative measure of remaining stone volume following intervention, observed on non-contrast CT (NCCT) (2.0mm slice thickness).
Outcome measures
| Measure |
Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System
n=28 kidneys
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).
Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System: 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).
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Residual Stone Volume (RSV)
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14.1 mm^3
Standard Deviation 23.0
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PRIMARY outcome
Timeframe: 30 DaysPopulation: All kidneys available at follow-up were analyzed.
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.
Outcome measures
| Measure |
Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System
n=28 kidneys
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).
Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System: 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).
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Stone Free Rate (SFR) - Zero Fragments
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13 kidneys
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Adverse Events
Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System
n=30 participants at risk
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).
Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System: 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).
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Renal and urinary disorders
Urinary Tract Infection (UTI)
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6.7%
2/30 • Number of events 2 • Index Procedure to Post-op Day-30 (POD30)
Adverse events (AEs) were collected and categorized by the investigators according to the Clavien-Dindo classification system.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60