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PMCF Investigation of MODULITH® SLX-F2 With StorM-Track in Patients With Kidney Stones
Sponsor: Storz Medical AG
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
Conditions
Interventions
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.
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