Kidney StonesNCT07514351
FANS vs CVAC for Medium to Large Stones
A study testing ureteroscopy and CVAC in people with Kidney Stones and Nephrolithiasis, run by Ohio State University at 1 site in United States.
Trial summary
Improvements in ureteroscopes have led to improved stone free rates. Two new devices (FANS - Flexible and Navigable Suction) and the CVAC ureteroscope have never been compared head to head. This trial will compare these two new suction ureteroscope technologies against each other Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stones, Nephrolithiasis
- What is being tested?
- ureteroscopy and CVAC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to Dec 2028
- 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
- Clinical diagnosis of Nephrolithiasis
- Total linear stone diameter 8-20 mm in size
Who cannot join
- Severe medical comorbidities causing inability to undergo general anesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ohio State University
Columbus, Ohio, 43212
Matthew Lee, 614-293-8155, matthew.lee@osumc.edu
About this study
Official title: Randomized Controlled Trial of Flexible and Navigable Suction (FANS) vs. CVAC Suction Ureteroscope for Medium to Large Stones
Improvements in ureteroscopes have led to improved stone free rates. Two new devices (FANS - Flexible and Navigable Suction) and the CVAC ureteroscope have never been compared head to head. This trial will compare these two new suction ureteroscope technologies against each other
Read the detailed description
Ureteroscopy (URS) is recommended by the American Urological Association for surgical treatment of kidney stones < 2 cm in linear dimension. Although historically shock wave lithotripsy was the most common surgical treatment, since 2013 ureteroscopy has become the most common surgical treatment for kidney stones. There have been great advancements to ureteroscopic technology with improvements in laser technology leading to more efficient and complete stone ablation/ fragmentation. However, stone free rates were still suboptimal, with some series reporting stone free rates of 55% after URS. However, in the last couple of years the introduction of suction technology, specifically Flexible and Navigable Suction (FANS) sheaths and the CVAC scope by Calyxo have changed the paradigm of kidney stone treatment. CVAC is essentially a larger ureteroscope with a large 7F working channel that allows for aspiration of stone fragments created during laser lithotripsy. A standard ureteroscope has a working channel of only 3.6 F so fragments cannot be aspirated through this. These new suction technologies allow the surgeon to actively remove stone fragments, thereby increasing the immediate and long-term stone free rate, instead of waiting for fragments to pass after the surgery.
- Conditions
- Kidney Stones, Nephrolithiasis
- Being tested
- ureteroscopy, CVAC
- Medical subject headings
- Kidney Calculi, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ureteroscopyDevice
ureteroscopy will be performed with flexible and navigable suction sheaths
CVACDevice
CVAC suction ureteroscopy will be used
| Study group | Role | What they receive |
|---|---|---|
| FANS | Active comparator | Flexible and Navigable Suction Ureteroscopy Receives: Device: ureteroscopy |
| CVAC | Active comparator | CVAC suction ureteroscopy arm Receives: Device: CVAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate
Journal of Endourology definitions using CT evidence
Measured: up to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Jul 2026
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Lee, Ohio State University
- Investigators
- Matthew Lee, MD, Principal investigator, Ohio State UniversityBodo Knudsen, MD, Principal investigator, Ohio State UniversityMichael Sourial, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514351
- Sponsor's protocol ID
- STUDY20260380
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified IPD will be shared with investigators upon written request and execution of a data use agreement with the Ohio State University
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Flexible and Navigable Suction (FANS) vs. CVAC Suction Ureteroscope for Medium to Large Stones
- ClinicalTrials.gov ID
- NCT07514351
- Acronym / sponsor ID
- STUDY20260380
- Conditions
- Kidney Stones, Nephrolithiasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 7 Apr 2026 (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.
Improvements in ureteroscopes have led to improved stone free rates. Two new devices (FANS - Flexible and Navigable Suction) and the CVAC ureteroscope have never been compared head to head. This trial will compare these two new suction ureteroscope technologies against each other
Detailed description
Ureteroscopy (URS) is recommended by the American Urological Association for surgical treatment of kidney stones < 2 cm in linear dimension. Although historically shock wave lithotripsy was the most common surgical treatment, since 2013 ureteroscopy has become the most common surgical treatment for kidney stones. There have been great advancements to ureteroscopic technology with improvements in laser technology leading to more efficient and complete stone ablation/ fragmentation. However, stone free rates were still suboptimal, with some series reporting stone free rates of 55% after URS. However, in the last couple of years the introduction of suction technology, specifically Flexible and Navigable Suction (FANS) sheaths and the CVAC scope by Calyxo have changed the paradigm of kidney stone treatment. CVAC is essentially a larger ureteroscope with a large 7F working channel that allows for aspiration of stone fragments created during laser lithotripsy. A standard ureteroscope has a working channel of only 3.6 F so fragments cannot be aspirated through this. These new suction technologies allow the surgeon to actively remove stone fragments, thereby increasing the immediate and long-term stone free rate, instead of waiting for fragments to pass after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FANS | Active comparator | Device: ureteroscopyFlexible and Navigable Suction Ureteroscopy |
| CVAC | Active comparator | Device: CVACCVAC suction ureteroscopy arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Nephrolithiasis
- Total linear stone diameter 8-20 mm in size
Key exclusion criteria (1 listed)
- Severe medical comorbidities causing inability to undergo general anesthesia
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 |
|---|---|---|
| ureteroscopyureteroscopy will be performed with flexible and navigable suction sheaths | Device | FANS |
| CVACCVAC suction ureteroscopy will be used | Device | CVAC |
Primary outcome
stone free rate
Time frame: up to six weeks
Journal of Endourology definitions using CT evidence
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 16 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified IPD will be shared with investigators upon written request and execution of a data use agreement with the Ohio State University
Related trials for Kidney Stones
Recruiting
Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
Kidney Stone
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
RecruitingPhase 3
Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention
Kidney Stone, Nephrolithiasis
RecruitingObservational study
Renal Stone Treatment Global Registry
Urolithiasis
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.
Matthew Lee, MD principal investigator
Ohio State University
Bodo Knudsen, MD principal investigator
Ohio State University
Michael Sourial, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ureteroscopy and CVAC in people with Kidney Stones and Nephrolithiasis, run by Ohio State University at 1 site 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 2 inclusion and 1 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Matthew Lee, MD (614-685-9181, matthew.lee@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stone free rate (time frame: up to six weeks). 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 16 Oct 2026.