Ohio State University
Columbus, Ohio, 43212, United States
NCT Number: NCT07514351
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
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Columbus, Ohio, 43212, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ureteroscopy will be performed with flexible and navigable suction sheaths
CVAC suction ureteroscopy will be used
Time frame: up to six weeks
Journal of Endourology definitions using CT evidence
Contact information is provided by the study sponsor or research team.
Ohio State University
Other
Randomized Controlled Trial of Flexible and Navigable Suction (FANS) vs. CVAC Suction Ureteroscope for Medium to Large Stones
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.
Published trials that share one or more normalized conditions with this study.
NCT07712861
Calculi, Female Urogenital Diseases
Buenos Aires, Argentina
View Trial DetailsNCT07705646
Calculi, Female Urogenital Diseases
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07516535
Calculi, Female Urogenital Diseases
Cairo, Egypt
View Trial DetailsNCT02214836
Calculi, Female Urogenital Diseases
Seattle, Washington, United States
View Trial Details