An interventional study of ESWL with kidney stone tracking (StorM-Track) and Standard ESWL without stone tracking (StorM-Track disabled) in Kidney Stones and Urolithiasis, sponsored by Storz Medical AG. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Storz Medical AG · Not applicable, Interventional, and Treatment
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.
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.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 126 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Storz Medical AG is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The presence of obstructions, malformations or other factors preventing targeting or passing of the stone, including but not limited to the following:
Any disease/medical condition, prior or concomitant medication/treatment/intervention, or implant that may affect this clinical investigation, and/or is for the IMD, including but not limited to the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: ESWL with kidney stone tracking (StorM-Track)
Device: Standard ESWL without stone tracking (StorM-Track disabled)
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.
Same treatment protocol as for the intervention group. If fragments \> 4mm remain after the first ESWL treatment, a 2nd ESWL will be performed.
Stone-free rate (SFR)
Proportion of subjects who are stone free or present with clinically insignificant residual fragments (measuring ≤ 4 mm on CT)
Time frame: 6±2 weeks post 1st treatment
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.
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 12±1 months post 1st treatment
Duration of hospital stay
The total number of days in hospital per subject
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: 12±1 months post 1st treatment
Mean total radiation dose area product (DAP) [μGy·m²] per subject
Time frame: 12±1 months post 1st treatment
Plan to share: No
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