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PMCF Investigation of MODULITH® SLX-F2 With StorM-Track in Patients With Kidney Stones

NCT07272720 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

  • Kidney Stones
  • Urolithiasis

Interventions

DEVICE

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

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.

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • Storz Medical AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-11
Primary Completion
2026-09-30
Completion
2027-07-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07272720 on ClinicalTrials.gov