Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCalyxo, Inc.
About this trial
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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- CVAC® SYSTEM
- FLEXIBLE AND NAVIGATIONAL URETERAL ACCESS SHEATH (FANS) IN FLEXIBLE URETEROSCOPY (FURS)
- DIRECT IN-SCOPE SUCTION (DISS) IN FLEXIBLE URETEROSCOPY (FURS)
- URETEROSCOPY (URS) WITHOUT SUCTION
- PERCUTANEOUS NEPHROLITHOTOMY (PCNL)
Treatment groups
1,000 Participants
are divided into 5 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov