RecruitingNot Applicable

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

Sweden126 participantsStarted 2025-12-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years
✓. Single kidney stone (6 - 15 mm) in the target kidney
✓. Stone density assessed by Hounsfield unit value (HU) ≤ 1,200 HU

Exclusion criteria

✕. BMI \> 29.9
✕. Target stone that cannot be localised
✕. Multiple kidney stones in the target kidney
✕. Stones with a density value of \> 1,200 HU
✕. Skin to stone distance (SSD) \> 160 mm
✕. The presence of obstructions, malformations or other factors preventing targeting or passing of the stone, including but not limited to the following:
✕. Skeletal malformations and obesity, preventing targeting of the stone
✕. Malignant tumour in the shockwave path

What they're measuring

Stone-free rate (SFR)

Timeframe: 6±2 weeks post 1st treatment

Trial details

NCT IDNCT07272720

SponsorStorz Medical AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09

Contact for this trial

Markus Hübscher, PhD

+41 (0)71 677 45 50 huebscher.markus@storzmedical.com

View on ClinicalTrials.gov More Kidney Stones trials