NCT07421843

Brief Summary

Extracorporeal shockwave lithotripsy (ESWL) is one way to treat renal stones. In this clinical trial our goal is to evaluate if two ESWL the same week is equal good and safe to two ESWL 3 weeks regarding renal stones 8-15 mm.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2022

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 19, 2026

Status Verified

January 1, 2026

Enrollment Period

3.5 years

First QC Date

January 20, 2026

Last Update Submit

February 11, 2026

Conditions

Kidney Stone

Outcome Measures

Primary Outcomes (3)

  • Time to stone free status

    Number of days from the day the treatment starts until the end of follow up.

    From enrollment until closure

  • Complications

    Are there any differences in complications

    From enrollment until closure

  • Number of participants considered stone free at follow up

    Number of participants who are stone free at the follow up after two ESWL. Stone status will be assessed with computer tomography.

    From enrollment until closure.

Secondary Outcomes (1)

  • Participant´s experiences

    From enrollment until closure

Study Arms (2)

ESWL, two days

ACTIVE COMPARATOR
Procedure: Extracorporeal shockwave lithotripsy (ESWL)

ESWL, three weeks

ACTIVE COMPARATOR
Procedure: Extracorporeal shockwave lithotripsy (ESWL)

Interventions

Extracorporeal shockwave lithotripsy (ESWL)PROCEDURE

ESWL, two treatments with an interval of two days or three weeks.

ESWL, three weeksESWL, two days

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Urology

Helsingborg, Sweden

Location

Department of Urology, KI Huddinge

Stockholm, Sweden

Location

MeSH Terms

Conditions

Kidney Calculi

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TherapeuticsUltrasonic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Magnus Wagenius, MD, PhD

    University of Lund

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomisation to ESWL with an interval of two days and with an interval of three weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2026

First Posted

February 19, 2026

Study Start

October 4, 2022

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

February 19, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)