PMCF Investigation of MODULITH® SLX-F2 With StorM-Track in Patients With Kidney Stones

Storz Medical

Status: Enrolling

Conditions: Urolithiasis; Kidney Stones

Treatments: Device: Standard ESWL without stone tracking (StorM-Track disabled); Device: ESWL with kidney stone tracking (StorM-Track)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07272720

CIV-25-05-052934

Details and patient eligibility

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.

Full description

The success of ESWL depends on multiple procedure- and patient-specific factors, one crucial factor being accurate stone targeting. Respiration induced kidney movement affects stone targeting as it results in the stone not being hit by the shock waves for up to 50% of the treatment time.

To improve the accuracy of stone targeting and comminution, an additional tracking module has been incorporated into the state-of-the-art lithotripter MODULITH® SLX-F2. The device is CE marked including its tracking module.

The scientific rationale for conducting this clinical investigation is based on the hypothesis that improved stone targeting through real-time tracking may lead to increased treatment efficacy and safety, as reflected by higher stone-free rates, reduced need for re-treatment, an increased quality of life, and lower adverse events rates.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

126 participants in 2 patient groups

ESWL with kidney stone tracking (StorM-Track).

Experimental group

Treatment:

Device: ESWL with kidney stone tracking (StorM-Track)

Standard ESWL without stone tracking (StorM-Track disabled).

Active Comparator group

Treatment:

Device: Standard ESWL without stone tracking (StorM-Track disabled)