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NCT Number: NCT07514351

FANS vs CVAC 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ureteroscopy

Device

ureteroscopy will be performed with flexible and navigable suction sheaths

CVAC

Device

CVAC suction ureteroscopy will be used

Primary outcomes

  1. stone free rate

    Time frame: up to six weeks

    Journal of Endourology definitions using CT evidence

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Lee, MD

CONTACT

[email protected]

614-685-9181

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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