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Active Not RecruitingNCT07225933

A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System

This is a retrospective, multi-center collaboration to assess real-world outcomes of a novel steerable aspiration system, the CVAC® System ("CVAC"), and flexible and navigable suction ureteral access ...

Lead sponsor: Calyxo, Inc.•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Calyxo, Inc.

Collaborators

University of California, San Diego
University of Alabama at Birmingham
University of Texas Southwestern Medical Center
OhioHealth Research Institute
Feinstein Institute for Medical Research
Summit Medical
Western New York Urology Associates

The objective of this study is observation of the safety and efficacy of subjects who underwent SURE procedure using the CVAC System or FANS for the removal of kidney stones in candidates for URS with laser lithotripsy. Efficacy will be observed by reviewing stone free status on standard of care post-procedure imaging. Safety will be observed by reviewing procedural information and if subjects had urologic events leading to Emergency Department (ED) visits, hospitalization, or retreatment.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Subjects that had SURE procedure with CVAC System performed in the retrospective cohort
•Subjects that had flexible URS (fURS) procedure with FANS performed in the retrospective cohort

Exclusion Criteria

•For planned SURE procedures, the inability for CVAC to gain access required for treatment of kidney stones

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 10, 2025Terms

Trial snapshot

StatusACTIVE_NOT_RECRUITING

Phase—

Enrollment3,000

Start dateFeb 2024

Last updatedNov 10, 2025

Condition

Urolithiasis Kidney Stone Kidney Stones

Locations shown

University of California San Diego (UCSD)

La Jolla, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 10, 2025Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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