Kidney StoneNCT04519294
Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE)
A study testing SURE and Standard Ureteroscopy (Basketing) in people with Kidney Stone and Renal Stone, run by Calyxo, Inc. at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone, Renal Stone, Urolithiasis
- What is being tested?
- SURE and Standard Ureteroscopy (Basketing)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 11 sitesUnited States
- Study dates
- 16 Jun 2021to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- BMI > 45;
- Significant comorbidities;
- Bladder, ureteral or kidney abnormalities;
- Pregnant individuals; or
- Unable to meet the treatment and follow up protocol requirements.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Albany Medical College
Albany, New York, 12208
Urology Austin
Austin, Texas, 78654
Dell Medical School, The University of Texas at Austin
Austin, Texas, 78712
Johns Hopkins
Baltimore, Maryland, 21287
UT Southwestern Medical Center
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27710
Prisma Health
Greenville, South Carolina, 29650
Mayo Clinic
Phoenix, Arizona, 85054
Arizona Institute of Urology
Tucson, Arizona, 85704
Urology of Virginia
Virginia Beach, Virginia, 23462
New Jersey Urology
Voorhees Township, New Jersey, 08043
About this study
Official title: A Prospective, Randomized Study to Evaluate the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation(SURE)Using the CVAC™ Aspiration System Compared to Basketing for the Removal of Renal Calculi Following Laser Lithotripsy
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.
- Conditions
- Kidney Stone, Renal Stone, Urolithiasis
- Being tested
- SURE, Standard Ureteroscopy (Basketing)
- Medical subject headings
- Kidney Calculi, Nephrolithiasis, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUREDevice
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)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| SURE | Active comparator | Not described Receives: Device: SURE |
| Standard Ureteroscopy (Basketing) | Active comparator | Not described Receives: Device: Standard Ureteroscopy (Basketing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 Days
Secondary outcomes (2)
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).
Measured: 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.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start16 Jun 2021
- Primary completion30 Jan 2023
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calyxo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519294
- Sponsor's protocol ID
- CP00001
- Status last verified
- Feb 2026
- First submitted
- 17 Aug 2020
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Study to Evaluate the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation(SURE)Using the CVAC™ Aspiration System Compared to Basketing for the Removal of Renal Calculi Following Laser Lithotripsy
- ClinicalTrials.gov ID
- NCT04519294
- Acronym / sponsor ID
- CP00001
- Conditions
- Kidney Stone, Renal Stone, Urolithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Calyxo, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 19 Aug 2020 (actual)
- Results
- Posted 27 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SURE | Active comparator | Device: SURE |
| Standard Ureteroscopy (Basketing) | Active comparator | Device: Standard Ureteroscopy (Basketing) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- BMI > 45;
- Significant comorbidities;
- Bladder, ureteral or kidney abnormalities;
- Pregnant individuals; or
- Unable to meet the treatment and follow up protocol requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUREThe 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. | Device | SURE |
| 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. | Device | Standard Ureteroscopy (Basketing) |
Primary outcome
Stone Free Rate (SFR) - Zero Fragments
Time frame: 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.
2 secondary outcomes
Residual Stone Volume (RSV)
Time frame: 30 Days
Stone Clearance (% Reduction in Stone Volume)
Time frame: 30 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SURE and Standard Ureteroscopy (Basketing) in people with Kidney Stone and Renal Stone, run by Calyxo, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone Free Rate (SFR) - Zero Fragments (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.