Kidney StonesNCT07272720
PMCF Investigation of MODULITH® SLX-F2 With StorM-Track in Patients With Kidney Stones
A study testing ESWL with kidney stone tracking (StorM-Track) and Standard ESWL without stone tracking (StorM-Track disabled) in people with Kidney Stones and Urolithiasis, run by Storz Medical AG at 1 site in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stones, Urolithiasis
- What is being tested?
- ESWL with kidney stone tracking (StorM-Track) and Standard ESWL without stone tracking (StorM-Track disabled)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSweden
- Study dates
- 11 Dec 2025to Oct 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Single kidney stone (6 - 15 mm) in the target kidney
- Stone density assessed by Hounsfield unit value (HU) ≤ 1,200 HU
Who cannot join
- BMI > 34.9
- Target stone that cannot be localised
- Presence of one or more additional stones > 4 mm in the target kidney
- 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
- Stones with a density value of > 1,200 HU
- Skin to stone distance (SSD) > 160 mm
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- The presence of obstructions, malformations or other factors preventing targeting or passing of the stone, including but not limited to the following:
- Skeletal malformations and obesity, preventing targeting of the stone
- Malignant tumour in the shockwave path
- Arterial aneurysm or calcium deposits, or thrombosis in shockwave path
- Brain, spinal column or air-filled tissue, especially the lungs, in the shockwave path
- Obstruction distal to the stone (as this would hinder the passage of fragments through collecting system or ureter)
- 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:
- Severe nephrocalcinosis
- Uncontrolled urinary tract infection
- Coagulation disorders and bleeding diathesis, not compensated according to urological and hemostaseological guidelines
- Anticoagulation or platelet inhibition therapy, not bridged according to urological and hemostaseological guidelines
- Uncontrolled hypertension
- Blood pressure > 180/100
- Active cardiac implants that are not authorized for use with ESWL
- Pancreatitis
- Ehlers-Danlos syndrome
- Administration of contrast agents containing gases for ultrasound diagnostics less than 24 hours before treatment.
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm
Tomas Thiel, MD, PhD, tomas.thiel@regionstockholm.se
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Stones, Urolithiasis
- Being tested
- ESWL with kidney stone tracking (StorM-Track), Standard ESWL without stone tracking (StorM-Track disabled)
- Keywords
- Kidney stones, Urolithiasis, Extracorporeal shockwave lithotripsy, ESWL
- Medical subject headings
- Kidney Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWL with kidney stone tracking (StorM-Track)Device
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.
Standard ESWL without stone tracking (StorM-Track disabled)Device
Same treatment protocol as for the intervention group.
If fragments > 4mm remain after the first ESWL treatment, a 2nd ESWL will be performed.
| Study group | Role | What they receive |
|---|---|---|
| ESWL with kidney stone tracking (StorM-Track). | Experimental | Not described Receives: Device: ESWL with kidney stone tracking (StorM-Track) |
| Standard ESWL without stone tracking (StorM-Track disabled). | Active comparator | Not described Receives: Device: Standard ESWL without stone tracking (StorM-Track disabled) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free rate (SFR)
Proportion of subjects who are stone free or present with clinically insignificant residual fragments (measuring ≤ 4 mm on CT)
Measured: 6±2 weeks post 1st treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start11 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Storz Medical AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Karolinska University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272720
- Sponsor's protocol ID
- CIV-25-05-052934
- Status last verified
- Jun 2026
- First submitted
- 19 Nov 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No