Calyxo | SCORE | NCT07155005

About

Kidney stones are hard mineral deposits that form in the kidney and affect roughly 1 in 10 people in the US. They can cause severe pain, blood in the urine, nausea, and infections, and often lead to emergency visits and repeat procedures. Stones are commonly treated with ureteroscopy, in which a thin scope is passed through the bladder to break up stones, or with surgery through the back. A challenge is that small stone fragments can be left behind and grow into new stones, so newer tools aim to remove fragments more completely.

Purpose

This observational study compares how safely and effectively different procedures remove kidney stones in everyday practice. It evaluates the CVAC® System, a single-use steerable catheter that combines vision, irrigation, and suction to remove stones, fragments, and dust. Results are compared with other options: percutaneous nephrolithotomy, standard ureteroscopy, and ureteroscopy with suction. The primary measure is the volume of stone left behind (residual stone volume) 30 days after the procedure. Patients receive the treatment their doctor has already planned; the study does not assign treatment.

Eligibility

• Adults willing and able to return for all study follow-up visits
• Are candidates for ureteroscopy with laser lithotripsy or percutaneous nephrolithotomy for kidney stones
• No untreated urinary tract infection or visible signs of infection at the time of the procedure
• No history of sepsis (a severe, life-threatening response to infection)

Benefits

If you qualify for the study, you may receive a stipend for your participation. You will still be responsible for your regular healthcare and treatment costs such as copays and deductibles.

Send us a message if you are interested in participating in a study.