Kidney Stone, Renal Stone, Urolithiasis
Conditions
Brief summary
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.
Interventions
DEVICESURE
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.
DEVICEStandard Ureteroscopy (Basketing)
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.
Sponsors
Calyxo, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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; * Presence of renal stone(s); * Be willing and able to return for all study-related follow up procedures; and, * Have been informed of the nature of the study, agreeing to its requirements, and have signed the IRB approved informed consent.
Exclusion criteria
* BMI \> 45; * Significant comorbidities; * Bladder, ureteral or kidney abnormalities; * Pregnant individuals; or * Unable to meet the treatment and follow up protocol requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone Free Rate (SFR) - Zero Fragments | 30 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual Stone Volume (RSV) | 30 Days | 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). |
| Stone Clearance (% Reduction in Stone Volume) | 30 Days | 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. |
Countries
United States
Participant flow
Pre-assignment details
In total, 132 subject were enrolled and treated. Of the subjects, 123 were randomized. Of these subjects, subjects whose study participation was discontinued prior to the 30-Day CT, who had poor CT quality, major protocol deviations, or who had their procedures aborted were not included in the efficacy analysis. A total of 101 subjects qualified for the efficacy analysis.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age | 59 years STANDARD_DEVIATION 13 |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 6 Participants |
| Race/Ethnicity, Customized White (Not Hispanic) | 80 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 24 Participants |
| Total stone burden | 17 mm STANDARD_DEVIATION 9 |
| Total stone volume | 610 mm^3 STANDARD_DEVIATION 510 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 65 |
| other Total, other adverse events | 4 / 67 | 5 / 65 |
| serious Total, serious adverse events | 1 / 67 | 2 / 65 |
Outcome results
None listed