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

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.

Study Overview

• Status: Recruiting
• Conditions: Urolithiasis; Kidney Stones
• Intervention / Treatment: Device: ESWL with kidney stone tracking (StorM-Track); Device: Standard ESWL without stone tracking (StorM-Track disabled)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Karolinska University Hospital
    • Contact: Tomas Thiel, MD, PhD; Email: tomas.thiel@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESWL with kidney stone tracking (StorM-Track).	Device: ESWL with kidney stone tracking (StorM-Track); Starting ESWL on a low energy setting with stepwise ramping and at a frequency of 1.0 or 1.5 Hz. Up to a maximum of 3'500 shockwaves unless there is no stone visible in X-ray imaging. If fragments > 4mm remain after the first ESWL treatment, a 2nd ESWL will be performed.
Active Comparator: Standard ESWL without stone tracking (StorM-Track disabled).	Device: Standard ESWL without stone tracking (StorM-Track disabled); Same treatment protocol as for the intervention group. If fragments > 4mm remain after the first ESWL treatment, a 2nd ESWL will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone-free rate (SFR)	Proportion of subjects who are stone free or present with clinically insignificant residual fragments (measuring ≤ 4 mm on CT)	6±2 weeks post 1st treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone free rate (SFR)	Proportion of subjects who are stone free or present with clinically insignificant residual fragments (measuring ≤ 4 mm on CT). Only for subjects who had a 2nd ESWL treatment at 6±2 weeks.	12±4 weeks post 1st treatment
Stone free rate	Proportion of subjects who are stone free or present with clinically insignificant residual fragments (measuring ≤ 4 mm on CT)	12±1 months post 1st treatment
Proportions of subjects with stone-free status classified into grades	Grade A (completely stone free, no stones on CT scan); Grade B (Grade A stones plus ≤ 2 mm fragments); Grade C (Grade A and B stones plus C 2.1 - 4 mm fragments)	6±2 weeks post 1st treatment
Proportions of subjects with stone-free status classified into grades	Grade A (completely stone free, no stones on CT scan); Grade B (Grade A stones plus ≤ 2 mm fragments); Grade C (Grade A and B stones plus C 2.1 - 4 mm fragments). Only for subjects who had a 2nd ESWL treatment at 6±2 weeks.	12±4 weeks post 1st treatment
Proportions of subjects with stone-free status classified into grades	Grade A (completely stone free, no stones on CT scan); Grade B (Grade A stones plus ≤ 2 mm fragments); Grade C (Grade A and B stones plus C 2.1 - 4 mm fragments)	12±1 months post 1st treatment
Change from baseline in the mean total WISQOL score	Wisconsin Stone Quality of Life Questionnaire (WISQOL). WISQOLTotal "raw" score = min-max 28-140 (lowest to highest QOL). WISQOLTotal "standardized" score = min-max 0-100 (lowest to highest QOL).	Baseline, 6±2 weeks post 1st treatment
ESWL re-treatment rate	The proportion of subjects with a need for re-treatment with ESWL during the 12 months follow-up period.	12±1 months post 1st treatment
Auxiliary procedures rate	The proportion of subjects with need for auxiliary procedures during the 12 months follow-up period.	12±1 months post 1st treatment
Duration of hospital stay	The total number of days in hospital per subject	12±1 months post 1st treatment
Total adverse device effect (ADE) rate	The number of ADEs (mild, moderate, severe; CTCAE v5.0 or higher) divided by the number of subjects.	6±2 weeks post 1st treatment
Total adverse device effect (ADE) rate	The number of ADEs (mild, moderate, severe; CTCAE v5.0 or higher) divided by the number of subjects. Only for subjects who had a 2nd ESWL treatment.	12±4 weeks post 1st treatment
Total adverse device effect (ADE) rate	The number of ADEs (mild, moderate, severe; CTCAE v5.0 or higher) divided by the number of subjects	12±1 months post 1st treatment
Adverse device effect (ADE) incidence	the number of subjects with one or more ADE (mild, moderate, severe; CTCAE v5.0 or higher)	6±2 weeks post 1st treatment
Adverse device effect (ADE) incidence	The number of subjects with one or more ADE (mild, moderate, severe; CTCAE v5.0 or higher). Only for subjects who had a 2nd ESWL treatment.	12±4 weeks post 1st treatment
Adverse device effect (ADE) incidence	The number of subjects with one or more ADE (mild, moderate, severe; CTCAE v5.0 or higher).	12±1 months post 1st treatment
Mean total radiation dose area product (DAP) [μGy·m²] per subject		12±1 months post 1st treatment

Collaborators and Investigators

• Sponsor: Storz Medical AG
• Collaborators: Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: ESWL; Urolithiasis; Kidney stones; Extracorporeal shockwave lithotripsy
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Calculi; Nephrolithiasis; Pathological Conditions, Signs and Symptoms; Kidney Calculi; Urolithiasis; Therapeutics; Surgical Procedures, Operative; Ultrasonic Surgical Procedures; Lithotripsy
• Other Study ID Numbers: CIV-25-05-052934

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No