Actively Recruiting
PMCF Investigation of MODULITH® SLX-F2 With StorM-Track in Patients With Kidney Stones
Led by Storz Medical AG · Updated on 2025-12-18
126
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
Sponsors
S
Storz Medical AG
Lead Sponsor
K
Karolinska University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PMCF Investigation of MODULITH® SLX-F2 With StorM-Track in Patients With Kidney Stones
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Single kidney stone between 6 and 15 millimeters in size in the target kidney
- Stone density of 1200 Hounsfield units or less
You will not qualify if you...
- Body mass index (BMI) over 29.9
- Kidney stone that cannot be located
- Multiple kidney stones in the target kidney
- Stone density over 1200 Hounsfield units
- Skin to stone distance greater than 160 millimeters
- Any obstruction, malformation, or condition preventing targeting or passage of the stone, including skeletal malformations, obesity, malignant tumors, arterial aneurysms, calcium deposits, thrombosis, brain or spinal column involvement, air-filled tissues in shockwave path, or distal obstruction to the stone
- Medical conditions or treatments affecting the study or contraindicating the device, including severe nephrocalcinosis, uncontrolled urinary tract infection, coagulation disorders, anticoagulation therapy not properly managed, uncontrolled hypertension, blood pressure above 180/100, unauthorized active cardiac implants, pancreatitis, Ehlers-Danlos syndrome, or recent use of contrast agents with gases
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Karolinska University Hospital
Stockholm, Sweden
Actively Recruiting
Research Team
M
Markus Hübscher, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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