NCT04519294

Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE)

Completed NA Results posted Last updated 27 February 2026

What this trial tests

NA trial testing SURE in Kidney Stone in 132 participants. Completed in 30 April 2025.

Timeline

16 June 2021

Primary endpoint
30 January 2023

30 April 2025

Quick facts

Lead sponsor	Calyxo, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	132
Start date	16 June 2021
Primary completion	30 January 2023
Estimated completion	30 April 2025
Sites	11 locations across United States

Drugs / interventions tested

• SURE
• Standard Ureteroscopy (Basketing)

Conditions studied

• Kidney Stone — all drugs for Kidney Stone →
• Renal Stone — all drugs for Renal Stone →
• Urolithiasis — all drugs for Urolithiasis →

Sponsor

Calyxo, Inc. — full company profile →

Who can join

18 and older, any sex, with Kidney Stone or Renal Stone. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Stone Free Rate (SFR) - Zero Fragments Primary · 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.

Group	Value	95% CI
SURE	48
Standard Ureteroscopy (Basketing)	49

Residual Stone Volume (RSV) Secondary · 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).

Group	Value	95% CI
SURE	14.3	± 30.9
Standard Ureteroscopy (Basketing)	70.2	± 144.9

Stone Clearance (% Reduction in Stone Volume) Secondary · 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.

Group	Value	95% CI
SURE	97.1	± 5.4
Standard Ureteroscopy (Basketing)	93.3	± 11.7

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 Day. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SURE

Serious: 1/67 (1%)

Deaths: 0/67

Standard Ureteroscopy (Basketing)

Serious: 2/65 (3%)

Deaths: 0/65

Serious adverse events (1 terms)

Reaction	System	SURE	Standard Ureteroscopy (Bas…
Sepsis Requiring Hospitalization	Renal and urinary disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	SURE	Standard Ureteroscopy (Bas…
Ureteral Damage	Renal and urinary disorders	—	—

Most-reported serious reactions: Sepsis Requiring Hospitalization.

Data from ClinicalTrials.gov NCT04519294 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Steerable Ureteroscopic Renal Evacuation (SURE) for Large Renal Stones: A Multi-Institutional Center Study.
   Stern KL, Borgert BJ, Wolf JS. · · 2023 · cited 13× · PMID 37639362 · DOI 10.1089/end.2023.0424