MODULITH SLX-F2 shockwave treatment with StorM-Track versus standard targeting for kidney stones
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
This will test if using StorM-Track real-time stone tracking with the MODULITH SLX-F2 shockwave machine helps adults with 6–15 mm kidney stones become stone-free more often than standard shockwave treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Storz Medical AG Industry-sponsored |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT07272720 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with a single kidney stone 6–15 mm in the target kidney, stone density ≤1,200 HU, BMI ≤29.9, and skin-to-stone distance ≤160 mm who can undergo ESWL are ideal candidates.
Not a fit: Patients with multiple target-kidney stones, stones >15 mm or density >1,200 HU, BMI >29.9, SSD >160 mm, non-localisable stones, or anatomical/obstructive factors preventing fragment passage are unlikely to benefit.
Why it matters
Potential benefit: If successful, the tracking module could increase stone-free rates, reduce repeat procedures, and lower complication rates for eligible patients.
How similar studies have performed: Prior small studies and device reports suggest real-time tracking can improve targeting and outcomes, but large controlled data are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 \> 29.9 2. Target stone that cannot be localised 3. Multiple kidney stones in the target kidney 4. Stones with a density value of \> 1,200 HU 5. Skin to stone distance (SSD) \> 160 mm 6. 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) 7. 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. 8. Pregnancy
Where this trial is running
Stockholm
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.