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FANS vs CVAC for Medium to Large Stones

Randomized Controlled Trial of Flexible and Navigable Suction (FANS) vs. CVAC Suction Ureteroscope for Medium to Large Stones

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07514351
Enrollment
159
Registered
2026-04-07
Start date
2026-06-01
Completion date
2028-12-01
Last updated
2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Stones, Nephrolithiasis

Brief 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

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.

Interventions

DEVICEureteroscopy

ureteroscopy will be performed with flexible and navigable suction sheaths

DEVICECVAC

CVAC suction ureteroscopy will be used

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of Nephrolithiasis * Total linear stone diameter 8-20 mm in size

Exclusion criteria

* Severe medical comorbidities causing inability to undergo general anesthesia

Design outcomes

Primary

MeasureTime frameDescription
stone free rateup to six weeksJournal of Endourology definitions using CT evidence

Countries

United States

Contacts

CONTACTMatthew Lee, MD
matthew.lee@osumc.edu614-685-9181
PRINCIPAL_INVESTIGATORMatthew Lee, MD

Ohio State University

PRINCIPAL_INVESTIGATORBodo Knudsen, MD

Ohio State University

PRINCIPAL_INVESTIGATORMichael Sourial, MD

Ohio State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026