FANS vs CVAC for Medium to Large Stones

The Ohio State University

Status: Begins enrollment this month

Conditions: Kidney Stones; Nephrolithiasis

Treatments: Device: ureteroscopy; Device: CVAC

Study type: Interventional

Funder types: Other

Identifiers

NCT07514351

STUDY20260380

Details and patient eligibility

About

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

Full 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.

Enrollment: 159 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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159 participants in 2 patient groups

FANS

Active Comparator group

Description:

Flexible and Navigable Suction Ureteroscopy

Treatment:

Device: ureteroscopy

CVAC

Active Comparator group

Description:

CVAC suction ureteroscopy arm

Treatment:

Device: CVAC