Smart tracking may boost kidney stone shockwave success
NCT ID NCT07272720
First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times
Summary
This study compares two versions of a shockwave machine for breaking kidney stones: one with stone tracking and one without. About 126 adults with a single kidney stone (6-15 mm) will be randomly assigned to either group. The goal is to see if the tracking feature helps more people become stone-free or have only tiny leftover fragments (4 mm or smaller).
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 126 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \> 34.9 2. Target stone that cannot be localised 3. Presence of one or more additional stones \> 4 mm in the target kidney 4. 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 5. Stones with a density value of \> 1,200 HU 6. Skin to stone distance (SSD) \> 160 mm 7. 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) 8. 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. 9. Pregnancy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Karolinska University Hospital
RECRUITINGStockholm, Sweden
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