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Not yet recruiting NCT07514351

FANS vs CVAC for Medium to Large Stones

No phase Interventional Kidney Stones Nephrolithiasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ureteroscopy, CVAC.
Who it may be relevant to
Registry conditions: Kidney Stones, Nephrolithiasis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Device ureteroscopy
    ureteroscopy will be performed with flexible and navigable suction sheaths
  • Device CVAC
    CVAC suction ureteroscopy will be used

Primary outcome measures

  • stone free rate [Time frame: up to six weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Ohio State University — Columbus

Identifiers

NCT: NCT07514351 · STUDY20260380

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗