PMCF Investigation of MODULITH® SLX-F2 With StorM-Track in Patients With Kidney Stones
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStorz Medical AG
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Single kidney stone (6 - 15 mm) in the target kidney
Stone density assessed by Hounsfield unit value (HU) ≤ 1,200 HU
Disqualifiers
BMI > 34.9
Target stone that cannot be localised
Presence of one or more additional stones > 4 mm in the target kidney
Presence of one or more additional stones ≤ 4 mm located in the same calyx (upper, mid, or lower pole) or in the renal pelvis as the target stone
Trial design
Treatments tested in this trial
- ESWL with kidney stone tracking (StorM-Track)
- Standard ESWL without stone tracking (StorM-Track disabled)
Treatment groups
126 Participants
are divided into 2 treatment groupsSponsors and collaborators
Storz Medical AG
Lead sponsor
Karolinska University Hospital
Collaborator
Source ClinicalTrials.gov