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
- Are there results?
- Not yet: the study is under way
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
Show all 24Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07272720
- Acronym / sponsor ID
- CIV-25-05-052934
- Conditions
- Kidney Stones, Urolithiasis
- Keywords
- Kidney stones, Urolithiasis, Extracorporeal shockwave lithotripsy, ESWL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Storz Medical AGIndustry (pharma, biotech, devices)
- Collaborators
- Karolinska University Hospital
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWL with kidney stone tracking (StorM-Track). | Experimental | Device: ESWL with kidney stone tracking (StorM-Track) |
| Standard ESWL without stone tracking (StorM-Track disabled). | Active comparator | Device: Standard ESWL without stone tracking (StorM-Track disabled) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Single kidney stone (6 - 15 mm) in the target kidney
- Stone density assessed by Hounsfield unit value (HU) ≤ 1,200 HU
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | ESWL with kidney stone tracking (StorM-Track). |
| 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. | Device | Standard ESWL without stone tracking (StorM-Track disabled). |
Primary outcome
Stone-free rate (SFR)
Time frame: 6±2 weeks post 1st treatment
Proportion of subjects who are stone free or present with clinically insignificant residual fragments (measuring ≤ 4 mm on CT)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Markus Hübscher, PhD (+41 (0)71 677 45 50, huebscher.markus@storzmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-free rate (SFR) (time frame: 6±2 weeks post 1st treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.