Trial Outcomes & Findings for Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE) (NCT NCT04519294)

NCT ID: NCT04519294

Last Updated: 2026-01-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

132 participants

Primary outcome timeframe

30 Days

Results posted on

2026-01-27

Participant Flow

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.

Participant milestones

Participant milestones
Measure	SURE SURE: 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.	Standard Ureteroscopy (Basketing) Standard 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.
Overall Study STARTED	46	55
Overall Study COMPLETED	43	50
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SURE n=46 Participants 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.	Standard Ureteroscopy (Basketing) n=55 Participants 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.	Total n=101 Participants Total of all reporting groups
Age, Customized Age	59 years STANDARD_DEVIATION 14 • n=25 Participants	60 years STANDARD_DEVIATION 14 • n=25 Participants	59 years STANDARD_DEVIATION 13 • n=50 Participants
Sex: Female, Male Female	22 Participants n=25 Participants	27 Participants n=25 Participants	49 Participants n=50 Participants
Sex: Female, Male Male	24 Participants n=25 Participants	28 Participants n=25 Participants	52 Participants n=50 Participants
Race/Ethnicity, Customized White (Not Hispanic)	36 Participants n=25 Participants	44 Participants n=25 Participants	80 Participants n=50 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=25 Participants	5 Participants n=25 Participants	7 Participants n=50 Participants
Race/Ethnicity, Customized Hispanic/Latino	7 Participants n=25 Participants	6 Participants n=25 Participants	13 Participants n=50 Participants
Race/Ethnicity, Customized Asian	1 Participants n=25 Participants	0 Participants n=25 Participants	1 Participants n=50 Participants
Total stone burden	14 mm STANDARD_DEVIATION 6.5 • n=25 Participants	19 mm STANDARD_DEVIATION 11 • n=25 Participants	17 mm STANDARD_DEVIATION 9 • n=50 Participants
Total stone volume	490 mm^3 STANDARD_DEVIATION 430 • n=25 Participants	710 mm^3 STANDARD_DEVIATION 560 • n=25 Participants	610 mm^3 STANDARD_DEVIATION 510 • n=50 Participants

PRIMARY outcome

Timeframe: 30 Days

Population: All patients who met all protocol requirements with no major deviations that compromise the ability to assess primary and secondary endpoints.

Outcome measures

Outcome measures
Measure	SURE n=46 Participants 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.	Standard Ureteroscopy (Basketing) n=55 Participants 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. Other Name:
Stone Free Rate (SFR) - Zero Fragments	48 % subjects	49 % subjects

SECONDARY outcome

Timeframe: 30 Days

Population: All patients who met all protocol requirements with no major deviations that compromise the ability to assess primary and secondary endpoints.

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).

Outcome measures

Outcome measures
Measure	SURE n=46 Participants 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.	Standard Ureteroscopy (Basketing) n=55 Participants 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. Other Name:
Residual Stone Volume (RSV)	14.3 mm^3 Standard Deviation 30.9	70.2 mm^3 Standard Deviation 144.9

SECONDARY outcome

Timeframe: 30 Days

Population: All patients who met all protocol requirements with no major deviations that compromise the ability to assess primary and secondary endpoints.

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.

Outcome measures

Outcome measures
Measure	SURE n=46 Participants 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.	Standard Ureteroscopy (Basketing) n=55 Participants 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. Other Name:
Stone Clearance (% Reduction in Stone Volume)	97.1 percent reduction (%) Standard Deviation 5.4	93.3 percent reduction (%) Standard Deviation 11.7

Adverse Events

SURE

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Standard Ureteroscopy (Basketing)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SURE n=67 participants at risk 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.	Standard Ureteroscopy (Basketing) n=65 participants at risk Standard 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.
Renal and urinary disorders Sepsis Requiring Hospitalization	1.5% 1/67 • Number of events 1 • 30 Day Reporting adverse events per requirements per the Results Data Element Definitions.	3.1% 2/65 • Number of events 2 • 30 Day Reporting adverse events per requirements per the Results Data Element Definitions.

Other adverse events

Other adverse events
Measure	SURE n=67 participants at risk 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.	Standard Ureteroscopy (Basketing) n=65 participants at risk Standard 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.
Renal and urinary disorders Ureteral Damage	6.0% 4/67 • Number of events 4 • 30 Day Reporting adverse events per requirements per the Results Data Element Definitions.	7.7% 5/65 • Number of events 5 • 30 Day Reporting adverse events per requirements per the Results Data Element Definitions.

Additional Information

Jacqueline Welch

Calyxo, Inc.

Phone: (925) 526-5900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60