NCT07272720

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Storz Medical AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The success of ESWL depends on multiple procedure- and patient-specific factors, one crucial factor being accurate stone targeting. Respiration induced kidney movement affects stone targeting as it results in the stone not being hit by the shock waves for up to 50% of the treatment time. To improve the accuracy of stone targeting and comminution, an additional tracking module has been incorporated into the state-of-the-art lithotripter MODULITH® SLX-F2. The device is CE marked including its tracking module. The scientific rationale for conducting this clinical investigation is based on the hypothesis that improved stone targeting through real-time tracking may lead to increased treatment efficacy and safety, as reflected by higher stone-free rates, reduced need for re-treatment, an increased quality of life, and lower adverse events rates.

Conditions

• Kidney Stones
• Urolithiasis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-11
• Primary completion: 2026-09-01
• Completion: 2027-07-01
• First posted: 2025-12-09
• Last updated: 2025-12-18

Locations

1 site across 1 country: Sweden