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

Recruiting N/A Interventional Study
Kidney Stones Urolithiasis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
126 (estimated)
Sponsor
Storz Medical AG · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Single kidney stone (6 - 15 mm) in the target kidney 3. Stone density assessed by Hounsfield unit value (HU) ≤ 1,200 HU Exclusion Criteria: 1. BMI \> 34.9 2. Target stone that cannot be localised 3. Presence of one or more additional stones \> 4 mm in the …
Contacts

Markus Hübscher, PhD

+41 (0)71 677 45 50

huebscher.markus@storzmedical.com

CONTACT