An interventional study of SURE and Standard Ureteroscopy (Basketing) in Kidney Stone, Renal Stone and Urolithiasis, sponsored by Calyxo, Inc.. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Calyxo, Inc. · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Device: SURE
Device: Standard Ureteroscopy (Basketing)
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.
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
| Milestone | SURE | Standard Ureteroscopy (Basketing) |
|---|---|---|
| Started | 46 | 55 |
| Completed | 43 | 50 |
| Not completed | 3 | 5 |
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.
| % subjects | SURE | Standard Ureteroscopy (Basketing) |
|---|---|---|
| Stone Free Rate (SFR) - Zero Fragments | 48 | 49 |
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).
| mm^3 | SURE | Standard Ureteroscopy (Basketing) |
|---|---|---|
| Residual Stone Volume (RSV) | 14.3 ± 30.9 | 70.2 ± 144.9 |
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.
| percent reduction (%) | SURE | Standard Ureteroscopy (Basketing) |
|---|---|---|
| Stone Clearance (% Reduction in Stone Volume) | 97.1 ± 5.4 | 93.3 ± 11.7 |
Collected over 30 Day. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SURE | 0/67 (0%) | 1/67 (1.5%) | 4/67 (6%) |
| Standard Ureteroscopy (Basketing) | 0/65 (0%) | 2/65 (3.1%) | 5/65 (7.7%) |
| Event | SURE | Standard Ureteroscopy (Basketing) |
|---|---|---|
| Sepsis Requiring HospitalizationRenal and urinary disorders | 1/67 | 2/65 |
| Event | SURE | Standard Ureteroscopy (Basketing) |
|---|---|---|
| Ureteral DamageRenal and urinary disorders | 4/67 | 5/65 |
| Age, Customized(years) | SURE | Standard Ureteroscopy (Basketing) | Total |
|---|---|---|---|
| Age | 59 ± 14 | 60 ± 14 | 59 ± 13 |
| Sex: Female, Male(Participants) | SURE | Standard Ureteroscopy (Basketing) | Total |
|---|---|---|---|
| Female | 22 | 27 | 49 |
| Male | 24 | 28 | 52 |
| Race/Ethnicity, Customized(Participants) | SURE | Standard Ureteroscopy (Basketing) | Total |
|---|---|---|---|
| White (Not Hispanic) | 36 | 44 | 80 |
| Black or African American | 2 | 5 | 7 |
| Hispanic/Latino | 7 | 6 | 13 |
| Asian | 1 | 0 | 1 |
| Total stone burden(mm) | SURE | Standard Ureteroscopy (Basketing) | Total |
|---|---|---|---|
| Mean | 14 ± 6.5 | 19 ± 11 | 17 ± 9 |
| Total stone volume(mm^3) | SURE | Standard Ureteroscopy (Basketing) | Total |
|---|---|---|---|
| Mean | 490 ± 430 | 710 ± 560 | 610 ± 510 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Calyxo, Inc.