An observational study in Urolithiasis, Stones, Kidney and Renal Stones, sponsored by Calyxo, Inc.. Recruiting at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Calyxo, Inc. · Observational
The goal of this clinical trial is to evaluate the effectiveness and safety of Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System versus other commonly used renal-stone interventions.
Up to 25 sites, and up to 250 subjects will be prospectively enrolled for phase 1: CVAC and FANS cohorts.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 160 across 96 observational studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Calyxo, Inc. is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Compared within Kidney Calculi, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Urolithiasis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Candidate for ureteroscopy with laser lithotripsy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a surgical procedure under general anesthesia, where a rigid probe is placed through the flank, creating a percutaneous tract into the renal collecting system under fluoroscopy. Via nephoscopy, stones are fragmented, pulverized, and extracted.
Procedure: PERCUTANEOUS NEPHROLITHOTOMY (PCNL)
DISS is a system that integrates controlled suction into the working channel of a standard flexible ureteroscope during ureteroscopic lithotripsy. A suction adapter is attached externally to the ureteroscope's working port, which connects to a standard hospital suction source.
Device: DIRECT IN-SCOPE SUCTION (DISS) IN FLEXIBLE URETEROSCOPY (FURS)
URS allows the surgeon to visualize the stone by inserting the ureteroscope into the ureter, most often a flexible scope that allows them to accommodate to the shape of the ureter and renal collecting system. A laser fiber is advanced through the working channel of the ureteroscope to perform stone fragmentation (dusting or breaking up the calculi). Once the stones are dusted or fragmented, the pieces can be removed by active extraction of individual stone fragments using a retrieval basket or using the concept of stone dusting where the fragments are small enough to be passed after the procedure.
Procedure: URETEROSCOPY (URS) WITHOUT SUCTION
FANS is designed to incorporate suction to facilitate stone fragment removal through its lumen and is used with a separate ureteroscope. FANS is fitted with a Y connector with a pressure control vent and connects to a standard vacuum device. A separate ureteroscope provides direct visualization and irrigation and a separate specimen collector captures stone debris.
Device: FLEXIBLE AND NAVIGATIONAL URETERAL ACCESS SHEATH (FANS) IN FLEXIBLE URETEROSCOPY (FURS)
The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).
Device: CVAC® SYSTEM
The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).
Also known as: SURE, CVAC
Group/Cohort Description: FANS is designed to incorporate suction to facilitate stone fragment removal through its lumen and is used with a separate ureteroscope. FANS is fitted with a Y connector with a pressure control vent and connects to a standard vacuum device. A separate ureteroscope provides direct visualization and irrigation and a separate specimen collector captures stone debris.
Also known as: FANS
DISS is a system that integrates controlled suction into the working channel of a standard flexible ureteroscope during ureteroscopic lithotripsy. A suction adapter is attached externally to the ureteroscope's working port, which connects to a standard hospital suction source.
Also known as: DISS
URS allows the surgeon to visualize the stone by inserting the ureteroscope into the ureter, most often a flexible scope that allows them to accommodate to the shape of the ureter and renal collecting system. A laser fiber is advanced through the working channel of the ureteroscope to perform stone fragmentation (dusting or breaking up the calculi). Once the stones are dusted or fragmented, the pieces can be removed by active extraction of individual stone fragments using a retrieval basket or using the concept of stone dusting where the fragments are small enough to be passed after the procedure.
Also known as: URS, Dusting, Basketing
This is a surgical procedure under general anesthesia, where a rigid probe is placed through the flank, creating a percutaneous tract into the renal collecting system under fluoroscopy. Via nephoscopy, stones are fragmented, pulverized, and extracted.
Also known as: PCNL
Residual Stone Volume (RSV)
Time frame: 30-Day
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Calyxo, Inc.