Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology

Launched by CALYXO, INC. · Jul 31, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to treat kidney stones: a newer method called Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System, and the standard method called ureteroscopy with laser lithotripsy. Both methods involve using a small tube to reach the kidney and remove or break up stones, but the study wants to see which approach works better. The trial will randomly assign patients to one of these treatments and take place at multiple medical centers.

People who might be eligible for this study are adults between 65 and 74 years old who need ureteroscopy with laser treatment for their kidney stones, are able to attend all follow-up visits, and have agreed to participate after learning about the study. Patients with untreated urinary infections, serious other health problems, abnormalities in their bladder, ureter, or kidneys, or those who are pregnant will not be able to join. If you participate, you can expect to receive one of the two treatments and have follow-up visits to check how well the treatment worked and monitor your recovery. This study is not yet recruiting participants but aims to help doctors understand which treatment might be safer and more effective for kidney stone removal.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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)
• Exclusion Criteria:
• • Untreated urinary tract infection at the time of the index procedure
• • Significant comorbidities
• • Bladder, ureteral or kidney abnormalities
• • Pregnant individuals
• • Unable to meet the treatment and follow up protocol requirements