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NCT07155005
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Conditions: Urolithiasis, Stones, Kidney, Renal Stones, Kidney Stones
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1000
Sponsor: Calyxo, Inc.
Location: University of Miami Miami Florida
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.
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
Source: ClinicalTrials.gov (NCT07155005). StuddyBuddy aggregates publicly available trial information.