Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCalyxo, Inc.
About this trial
The goal of this clinical trial is to compare Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and standard ureteroscopy (URS) with laser lithotripsy for the treatment of urolithiasis. This is a prospective, randomized (1:1), multi-center study.
Eligibility criteria
Qualifiers
Candidate for ureteroscopy with laser lithotripsy
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
Significant comorbidities
Bladder, ureteral or kidney abnormalities
Pregnant individuals
Trial design
Treatments tested in this trial
- Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System
- Standard Ureteroscopy (URS)
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov