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Smart tracking may boost kidney stone shockwave success

NCT ID NCT07272720

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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).

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 126 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • Karolinska University Hospital

    RECRUITING

    Stockholm, Sweden

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