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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
ESWL with kidney stone tracking (StorM-Track)
DeviceStarting 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.
Standard ESWL without stone tracking (StorM-Track disabled)
DeviceSame treatment protocol as for the intervention group. If fragments \> 4mm remain after the first ESWL treatment, a 2nd ESWL will be performed.
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: ESWL with kidney stone tracking (StorM-Track).Experimental treatment 1 intervention
Group B: Standard ESWL without stone tracking (StorM-Track disabled).Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Stone-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 treatmentOther outcomes
1
Stone free rate (SFR)
Proportion of subjects who are stone free or present with clinically insignificant residual fragments (measuring ≤ 4 mm on CT). Only for subjects who had a 2nd ESWL treatment at 6±2 weeks.
Time frame
12±4 weeks post 1st treatment2
Stone free rate
Proportion of subjects who are stone free or present with clinically insignificant residual fragments (measuring ≤ 4 mm on CT)
Time frame
12±1 months post 1st treatment3
Proportions of subjects with stone-free status classified into grades
Grade A (completely stone free, no stones on CT scan); Grade B (Grade A stones plus ≤ 2 mm fragments); Grade C (Grade A and B stones plus C 2.1 - 4 mm fragments)
Time frame
6±2 weeks post 1st treatment4
Proportions of subjects with stone-free status classified into grades
Grade A (completely stone free, no stones on CT scan); Grade B (Grade A stones plus ≤ 2 mm fragments); Grade C (Grade A and B stones plus C 2.1 - 4 mm fragments). Only for subjects who had a 2nd ESWL treatment at 6±2 weeks.
Time frame
12±4 weeks post 1st treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Storz Medical AG
Lead sponsor
Karolinska University Hospital
Collaborator
Source ClinicalTrials.gov