NCT07272720

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Dec 2025Jul 2027

First Submitted

Initial submission to the registry

November 19, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

December 11, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

November 19, 2025

Last Update Submit

December 11, 2025

Conditions

Kidney StonesUrolithiasis

Keywords

Kidney stonesUrolithiasisExtracorporeal shockwave lithotripsyESWL

Outcome Measures

Primary Outcomes (1)

  • Stone-free rate (SFR)

    Proportion of subjects who are stone free or present with clinically insignificant residual fragments (measuring ≤ 4 mm on CT)

    6±2 weeks post 1st treatment

Other Outcomes (16)

  • Stone free rate (SFR)

    12±4 weeks post 1st treatment

  • Stone free rate

    12±1 months post 1st treatment

  • Proportions of subjects with stone-free status classified into grades

    6±2 weeks post 1st treatment

  • +13 more other outcomes

Study Arms (2)

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)

Interventions

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.

ESWL with kidney stone tracking (StorM-Track).
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.

Standard ESWL without stone tracking (StorM-Track disabled).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Single kidney stone (6 - 15 mm) in the target kidney
  • Stone density assessed by Hounsfield unit value (HU) ≤ 1,200 HU

You may not qualify if:

  • BMI \> 29.9
  • Target stone that cannot be localised
  • Multiple kidney stones in the target kidney
  • Stones with a density value of \> 1,200 HU
  • Skin to stone distance (SSD) \> 160 mm
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Kidney CalculiUrolithiasis

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsUltrasonic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Markus Hübscher, PhD

CONTACT

+41 (0)71 677 45 50huebscher.markus@storzmedical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2025

First Posted

December 9, 2025

Study Start

December 11, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)