PMCF Investigation of MODULITH® SLX-F2 With StorM-Track in Patients With Kidney Stones
Recruiting now · Not applicable
Conditions studied: Kidney Stones, Urolithiasis
In brief
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.
Key facts
- Study ID
- NCT07272720
- Run by
- Storz Medical AG
- People needed
- 126
- Starts
- 2025-12-11
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2026-06-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- Single kidney stone (6 - 15 mm) in the target kidney
- Stone density assessed by Hounsfield unit value (HU) ≤ 1,200 HU
You may not qualify if…
- 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
- Stones with a density value of > 1,200 HU
- Skin to stone distance (SSD) > 160 mm
- The presence of obstructions, malformations or other factors preventing targeting or passing of the stone, including but not limited to the following:
- Skeletal malformations and obesity, preventing targeting of the stone
- Malignant tumour in the shockwave path
- Arterial aneurysm or calcium deposits, or thrombosis in shockwave path
- Brain, spinal column or air-filled tissue, especially the lungs, in the shockwave path
- Obstruction distal to the stone (as this would hinder the passage of fragments through collecting system or ureter)
- Any disease/medical condition, prior or concomitant medication/treatment/intervention, or implant that may affect this clinical investigation, and/or is contraindicated for the IMD, including but not limited to the following:
- Severe nephrocalcinosis
- Uncontrolled urinary tract infection
- Coagulation disorders and bleeding diathesis, not compensated according to urological and hemostaseological guidelines
- Anticoagulation or platelet inhibition therapy, not bridged according to urological and hemostaseological guidelines
- Uncontrolled hypertension
- Blood pressure > 180/100
- Active cardiac implants that are not authorized for use with ESWL
- Pancreatitis
- Ehlers-Danlos syndrome
- Administration of contrast agents containing gases for ultrasound diagnostics less than 24 hours before treatment.
- Pregnancy
Where it is running
- Karolinska University Hospital — Stockholm, Sweden (enrolling)
Full record on ClinicalTrials.gov
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