MODULITH SLX-F2 shockwave treatment with StorM-Track versus standard targeting for kidney stones

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study compares extracorporeal shockwave lithotripsy (ESWL) performed with the MODULITH SLX-F2 using the StorM-Track real-time stone tracking module to the same device with tracking disabled. Adult patients with a single kidney stone 6–15 mm in size and stone density ≤1,200 HU are enrolled and treated at a single center. The primary outcome is stone-free status after treatment, with secondary outcomes including need for re-treatment, quality of life, and adverse event rates. The device and tracking module are CE marked and the tracking system is designed to compensate for respiration-induced kidney movement to improve targeting accuracy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years
2. Single kidney stone (6 - 15 mm) in the target kidney
3. Stone density assessed by Hounsfield unit value (HU) ≤ 1,200 HU

Exclusion Criteria:

1. BMI \> 34.9
2. Target stone that cannot be localised
3. Presence of one or more additional stones \> 4 mm in the target kidney
4. 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
5. Stones with a density value of \> 1,200 HU
6. Skin to stone distance (SSD) \> 160 mm
7. The presence of obstructions, malformations or other factors preventing targeting or passing of the stone, including but not limited to the following:

   1. Skeletal malformations and obesity, preventing targeting of the stone
   2. Malignant tumour in the shockwave path
   3. Arterial aneurysm or calcium deposits, or thrombosis in shockwave path
   4. Brain, spinal column or air-filled tissue, especially the lungs, in the shockwave path
   5. Obstruction distal to the stone (as this would hinder the passage of fragments through collecting system or ureter)
8. 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:

   1. Severe nephrocalcinosis
   2. Uncontrolled urinary tract infection
   3. Coagulation disorders and bleeding diathesis, not compensated according to urological and hemostaseological guidelines
   4. Anticoagulation or platelet inhibition therapy, not bridged according to urological and hemostaseological guidelines
   5. Uncontrolled hypertension
   6. Blood pressure \> 180/100
   7. Active cardiac implants that are not authorized for use with ESWL
   8. Pancreatitis
   9. Ehlers-Danlos syndrome
   10. Administration of contrast agents containing gases for ultrasound diagnostics less than 24 hours before treatment.
9. Pregnancy

Where it's running

• Karolinska University Hospital
  Stockholm, Sweden Recruiting

Study contacts

• Study coordinator: Markus Hübscher, PhD
• Email: huebscher.markus@storzmedical.com
• Phone: +41 (0)71 677 45 50

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.