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Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study

Evaluating the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC® System Compared to Other Therapeutic Interventions for the Treatment of Renal Stones: a Prospective, Observational Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07155005
Acronym
SCORE
Enrollment
1000
Registered
2025-09-04
Start date
2026-03-16
Completion date
2029-04-01
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Stones, Renal Stones, Stones, Kidney, Urolithiasis

Keywords

ureteroscopy, CVAC, SURE, URS

Brief summary

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.

Detailed description

Up to 25 sites, and up to 250 subjects will be prospectively enrolled for phase 1: CVAC and FANS cohorts.

Interventions

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).

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.

DEVICEDIRECT IN-SCOPE SUCTION (DISS) IN FLEXIBLE URETEROSCOPY (FURS)

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.

PROCEDUREURETEROSCOPY (URS) WITHOUT SUCTION

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.

PROCEDUREPERCUTANEOUS NEPHROLITHOTOMY (PCNL)

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.

Sponsors

Calyxo, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Candidate for ureteroscopy with laser lithotripsy or PCNL for the treatment of renal stones * Be willing and able to return for and respond to all study-related follow up procedures * Have been informed of the nature of the study and has provided informed consent using the IRB approved informed consent (ICF)

Exclusion criteria

* Untreated urinary tract infection at the time of the index procedure * Visual evidence of infection at the time of the index procedure * History of sepsis * Significant comorbidities * Bladder, ureteral or kidney abnormalities * Pregnant individuals * Unable to meet the treatment and follow up protocol requirements

Design outcomes

Primary

MeasureTime frame
Residual Stone Volume (RSV)30-Day

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026