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RECRUITING
NCT07272720
NA

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

Sponsor: Storz Medical AG

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2025-12-11

Completion Date

2027-07

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

DEVICE

ESWL 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.

DEVICE

Standard 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.

Locations (1)

Karolinska University Hospital

Stockholm, Sweden