N/A
N=101
Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE)
Kidney Stone · Renal Stone · Urolithiasis
Bottom Line
View on ClinicalTrials.gov: NCT04519294 ↗Enrolled (actual)
101
Serious AEs
2.3%
Results posted
Jan 2026
Primary outcome: Primary: Stone Free Rate (SFR) - Zero Fragments — 48; 49 % subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SURE (Device); Standard Ureteroscopy (Basketing) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Calyxo, Inc.
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stone Free Rate (SFR) - Zero Fragments |
48; 49 | — |
| SECONDARY Residual Stone Volume (RSV) |
14.3; 70.2 | — |
| SECONDARY Stone Clearance (% Reduction in Stone Volume) |
97.1; 93.3 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04519294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.