UrolithiasisTRUSTNCT07101809
Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
A study testing Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and Standard Ureteroscopy (URS) in people with Urolithiasis and Stones, Kidney, run by Calyxo, Inc. at 5 sites in United States.
Trial summary
The goal of this clinical trial is to compare Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and standard ureteroscopy (URS) with laser lithotripsy for the treatment of urolithiasis. This is a prospective, randomized (1:1), multi-center study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis, Stones, Kidney, Renal Stones
- What is being tested?
- Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and Standard Ureteroscopy (URS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesUnited States
- Study dates
- 21 May 2026to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Be willing and able to return for and respond to all study-related follow up procedures
- Have been informed of the nature of the study and has provided informed consent using the IRB approved informed consent (ICF)
Who cannot join
- Untreated urinary tract infection at the time of the index procedure
- Significant comorbidities
- Bladder, ureteral or kidney abnormalities
- Pregnant individuals
- Unable to meet the treatment and follow up protocol requirements
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
The University of Texas at Austin, Dell Medical School
Austin, Texas, 78712
Swetha Venkataraman, 512-495-2201, swetha.venkataraman@austin.utexas.edu
- Recruiting
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
Cheryl Zinar, RN, BSN, 610-667-0458 ext. Opt. 2, czinar@midlanticurology.com
- Recruiting
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Samuel P. Dransfield, MS, 205-641-6620, sdransfield@uabmc.edu
- Recruiting
University of Florida
Gainesville, Florida, 32611
John Marks, 352-273-5618, marksjg@ufl.edu
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Monali Fatterpekar, PhD, 212-241-0751, monali.fatterpekar@mountsinai.org
About this study
Official title: Evaluating the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC® System Compared to Standard Ureteroscopy With no Suction for the Treatment of Renal Stones: a Prospective, Randomized Trial
The goal of this clinical trial is to compare Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and standard ureteroscopy (URS) with laser lithotripsy for the treatment of urolithiasis. This is a prospective, randomized (1:1), multi-center study.
- Conditions
- Urolithiasis, Stones, Kidney, Renal Stones, Kidney Stones
- Being tested
- Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System, Standard Ureteroscopy (URS)
- Keywords
- ureteroscopy, CVAC, SURE
- Medical subject headings
- Urolithiasis, Kidney Calculi, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC SystemDevice
Also called CVAC
The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).
Standard Ureteroscopy (URS)Device
Arm Description: This is a treatment in which the urologist uses a laser to break a kidney stone into very small pieces and then places a tool called a stent to allows the remaining pieces to fall out.
| Study group | Role | What they receive |
|---|---|---|
| Standard Ureteroscopy (URS) | Active comparator | This is a treatment in which the urologist uses a laser to break a kidney stone into very small pieces and then places a tool called a stent to allows the remaining pieces to fall out. Receives: Device: Standard Ureteroscopy (URS) |
| Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC System | Active comparator | The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust). Receives: Device: Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Stone Volume (RSV)
Measured: 30-Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start21 May 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Calyxo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101809
- Sponsor's protocol ID
- CP00006
- Acronym
- TRUST
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC® System Compared to Standard Ureteroscopy With no Suction for the Treatment of Renal Stones: a Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT07101809
- Acronym / sponsor ID
- TRUST / CP00006
- Conditions
- Urolithiasis, Stones, Kidney, Renal Stones, Kidney Stones
- Keywords
- ureteroscopy, CVAC, SURE
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Calyxo, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 May 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and standard ureteroscopy (URS) with laser lithotripsy for the treatment of urolithiasis. This is a prospective, randomized (1:1), multi-center study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Ureteroscopy (URS) | Active comparator | Device: Standard Ureteroscopy (URS)This is a treatment in which the urologist uses a laser to break a kidney stone into very small pieces and then places a tool called a stent to allows the remaining pieces to fall out. |
| Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC System | Active comparator | Device: Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC SystemThe CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Candidate for ureteroscopy with laser lithotripsy
- Be willing and able to return for and respond to all study-related follow up procedures
- Have been informed of the nature of the study and has provided informed consent using the IRB approved informed consent (ICF)
Key exclusion criteria (5 listed)
- Untreated urinary tract infection at the time of the index procedure
- Significant comorbidities
- Bladder, ureteral or kidney abnormalities
- Pregnant individuals
- 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 |
|---|---|---|
| Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC SystemAlso: CVACThe CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust). | Device | Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC System |
| Standard Ureteroscopy (URS)Arm Description: This is a treatment in which the urologist uses a laser to break a kidney stone into very small pieces and then places a tool called a stent to allows the remaining pieces to fall out. | Device | Standard Ureteroscopy (URS) |
Primary outcome
Residual Stone Volume (RSV)
Time frame: 30-Day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
Related trials for Urolithiasis
Recruiting
Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
Kidney Stone
Recruiting
The Effect of Acupuncture on Passing Ureteral Stones
Ureter Calculi
RecruitingObservational study
Comparison of Trans-Stomial Bladder Lithotripsy Using Mini-Percutaneous Equipment Versus Trans-stomial Bladder Lithotripsy Using Flexible Fibroscope, Percutaneous Approach and Open Cystolithotomy in Patients With Continent Catheterizable Urinary Reservoir
Bladder Calculi, Continent Catheterizable Urinary Reservoir
Not yet recruitingObservational study
Novel Antimicrobial Solution to Prevent Infections
Kidney Stone, Infection
Not yet recruiting
DISS vs FANS in Suction-Assisted RIRS for Medium-Sized Renal Stones
Kidney Stones, Nephrolithiasis
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.
Icahn School of Medicine at Mount Sinai
New York, United States
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and Standard Ureteroscopy (URS) in people with Urolithiasis and Stones, Kidney, run by Calyxo, Inc. at 5 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 3 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: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual Stone Volume (RSV) (time frame: 30-Day). 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 23 Jul 2026.