Post-Market Clinical Follow-Up Investigation of MODULITH® SLX-F2 With StorM-Track in Patients With Kidney Stones - A Confirmatory Parallel-Group, Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Extracorporeal shockwave lithotripsy (ESWL) is a non-invasive standard treatment for kidney stones. This stud 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years
• Single kidney stone (6 - 15 mm) in the target kidney
• Stone density assessed by Hounsfield unit value (HU) ≤ 1,200 HU
Locations
Other Locations
Sweden
Karolinska University Hospital
RECRUITING
Stockholm
Contact Information
Primary
Markus Hübscher, PhD
huebscher.markus@storzmedical.com
+41 (0)71 677 45 50
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2027-07
Participants
Target number of participants: 126
Treatments
Experimental: ESWL with kidney stone tracking (StorM-Track).
Active_comparator: Standard ESWL without stone tracking (StorM-Track disabled).
Related Therapeutic Areas
Sponsors
Collaborators: Karolinska University Hospital
Leads: Storz Medical AG