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Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
RecruitingObservational 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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- 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)
Sponsor: Calyxo, Inc. · Participants: 1,000 · Started: Oct 12, 2026
Contact the study team
Official record on ClinicalTrials.gov — NCT07155005
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.