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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
126
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.
Same treatment protocol as for the intervention group. If fragments \> 4mm remain after the first ESWL treatment, a 2nd ESWL will be performed.
Karolinska University Hospital
Stockholm, Sweden
RECRUITINGStone-free rate (SFR)
Proportion of subjects who are stone free or present with clinically insignificant residual fragments (measuring ≤ 4 mm on CT)
Time frame: 6±2 weeks post 1st treatment
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