Kidney Stone, Renal Stones, Urolithiasis
Conditions
Brief summary
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.
Interventions
DEVICESteerable 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).
Sponsors
Calyxo, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Candidate for ureteroscopy with laser lithotripsy; * Be willing and able to return for and respond to all study-related follow up procedures; and, * Have been informed of the nature of the study and have agreed to the IRB approved informed consent form (ICF).
Exclusion criteria
* Significant morbidities; * Unable to meet the treatment and follow up protocol requirements; and, * Ureteral or kidney abnormalities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone Clearance (% Reduction in Stone Volume) | 30 Days | 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. |
| Residual Stone Volume (RSV) | 30 Days | A continuous quantitative measure of remaining stone volume following intervention, observed on non-contrast CT (NCCT) (2.0mm slice thickness). |
| Stone Free Rate (SFR) - Zero Fragments | 30 Days | 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. |
Countries
India
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 48 years STANDARD_DEVIATION 16.2 |
| Region of Enrollment India | 30 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 20 Participants |
| Stone Density | 1203 HU STANDARD_DEVIATION 345 |
| Total Stone Volume | 703.6 mm^3 STANDARD_DEVIATION 835.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 2 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
None listed