An interventional study of ureteroscopy and CVAC in Kidney Stones and Nephrolithiasis, sponsored by Ohio State University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
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
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.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 159 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.
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Exclusion Criteria:
Flexible and Navigable Suction Ureteroscopy
Device: ureteroscopy
CVAC suction ureteroscopy arm
Device: CVAC
ureteroscopy will be performed with flexible and navigable suction sheaths
CVAC suction ureteroscopy will be used
stone free rate
Journal of Endourology definitions using CT evidence
Time frame: up to six weeks
Plan to share: Yes — De-identified IPD will be shared with investigators upon written request and execution of a data use agreement with the Ohio State University
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: 1 year after study completion
Access criteria: any investigators who provide written request and complete a data use agreement
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jun 2028, 23 months after the start.
Of 183 non-industry interventional studies with no phase under Kidney Calculi, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 23 months is below that.
Counting every sponsor, half of 199 studies reached it within 26 months; a quarter within 12 and three quarters within 51.
Start moved once since we started tracking on Sep 25, 2026: Jun 2026 → Jul 2026, on Oct 16, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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