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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System
DeviceThe CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).
Standard Ureteroscopy (URS)
DeviceArm Description: This is a treatment in which the urologist uses a laser to break a kidney stone into very small pieces and then places a tool called a stent to allows the remaining pieces to fall out.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Standard Ureteroscopy (URS)Active comparator 1 intervention
Group B: Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC SystemActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Residual Stone Volume (RSV)
Time frame
30-DaySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov