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Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study | Clinical Trials | Clareo Health

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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

NCT07155005•Calyxo, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

March 16, 2026

Primary Completion Date

April 1, 2028

Completion Date

April 1, 2029

Last Updated

March 12, 2026

Enrollment

1,000

ESTIMATED participants

Conditions

UrolithiasisStones, KidneyRenal StonesKidney Stones

Interventions

CVAC® SYSTEM

DEVICE

FLEXIBLE AND NAVIGATIONAL URETERAL ACCESS SHEATH (FANS) IN FLEXIBLE URETEROSCOPY (FURS)

DEVICE

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

DEVICE

URETEROSCOPY (URS) WITHOUT SUCTION

PROCEDURE

PERCUTANEOUS NEPHROLITHOTOMY (PCNL)

PROCEDURE

A Comparative Study Between the Usage of Flexible and Navigable Suction Ureteral Access Sheath Versus Traditional Access Sheath in Retrograde Intrarenal Surgeries

NCT07076589

Stones, KidneyUreter Stones

View study

RECRUITINGNA

Evaluation of Quality of Life in Patients After Placement of a Modified Double J Ureteral Stent

NCT07275879

Ureteral Double-J StentUrolithiasis+1 more

View study

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: March 12, 2026Data synced to Clareo: March 29, 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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Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study

Inclusion Criteria

Exclusion Criteria

A Comparative Study Between the Usage of Flexible and Navigable Suction Ureteral Access Sheath Versus Traditional Access Sheath in Retrograde Intrarenal Surgeries

Evaluation of Quality of Life in Patients After Placement of a Modified Double J Ureteral Stent

Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure

Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease

Renal Stone Treatment Global Registry

Multiomics Biomarkers for Urolithiasis