PMCF Investigation of MODULITH® SLX-F2 With StorM-Track in Patients With Kidney Stones (NCT07272720) | Clinical Trial Compass
RecruitingNot Applicable
PMCF Investigation of MODULITH® SLX-F2 With StorM-Track in Patients With Kidney Stones
Sweden126 participantsStarted 2025-12-11
Plain-language 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 stone-free status.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years
. Single kidney stone (6 - 15 mm) in the target kidney
. Stone density assessed by Hounsfield unit value (HU) ≤ 1,200 HU
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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