RecruitingNot ApplicableNCT07272720

PMCF Investigation of MODULITH® SLX-F2 With StorM-Track in Patients With Kidney Stones

Post-Market Clinical Follow-Up Investigation of MODULITH® SLX-F2 With StorM-Track in Patients With Kidney Stones - A Confirmatory Parallel-Group, Randomized Controlled Trial

Sponsor

Storz Medical AG

Enrollment

126 participants

Start Date

Dec 11, 2025

Study Type

INTERVENTIONAL

Conditions

Kidney Stones Urolithiasis

Summary

Extracorporeal shockwave lithotripsy (ESWL) is a non-invasive standard treatment for kidney stones. This study will be conducted to evaluate the effectiveness of ESWL using MODULITH® SLX-F2 with stone tracking, compared to MODULITH® SLX-F2 without stone tracking, in adult patients with kidney stones, as measured by stone-free status.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called ESWL with kidney stone tracking (StorM-Track) and a medical device called Standard ESWL without stone tracking (StorM-Track disabled) for people with kidney stones and urolithiasis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEESWL with kidney stone tracking (StorM-Track)

Starting ESWL on a low energy setting with stepwise ramping and at a frequency of 1.0 or 1.5 Hz. Up to a maximum of 3'500 shockwaves unless there is no stone visible in X-ray imaging. If fragments \> 4mm remain after the first ESWL treatment, a 2nd ESWL will be performed.

DEVICEStandard ESWL without stone tracking (StorM-Track disabled)

Same treatment protocol as for the intervention group. If fragments \> 4mm remain after the first ESWL treatment, a 2nd ESWL will be performed.