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.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's enrollment of 132 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Calyxo, Inc. is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2021 to primary completion in Jan 2023, 19 months.
Results were first posted in Jan 2026, 2 years 11 months after primary completion.
Of 199 interventional studies with no phase under Kidney Calculi, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's 19 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Calyxo, Inc.