Pediatric UrolithiasisSWE-ESWLNCT07506031
Shear Wave Elastography for Predicting Extracorporeal Shock Wave Lithotripsy Outcomes in Pediatric Renal Stones
An observational study of Pediatric Urolithiasis, run by Beni-Suef University at 1 site in Egypt.
Trial summary
This prospective study aims to evaluate the role of shear wave elastography (SWE) as a non-invasive and radiation-free tool for predicting the success of extracorporeal shock wave lithotripsy (ESWL) in pediatric patients with renal stones. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Pediatric Urolithiasis
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Dec 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients under 18 years of age diagnosed with renal stones measuring 6-20 mm and scheduled for extracorporeal shock wave lithotripsy (ESWL). Patients will be recruited from the outpatient clinic and followed for 3 months. Proper history, examination and basic laboratory investigations (CBC, coagulation profile, kidney and Liver functions, urine analysis and urine culture and sensitivity) will be performed for all participants. Low dose CTUT will be performed as usual for all patient to record stone location, size (maximum longitudinal and transverse dimensions), and HU. Renal stone elastography values will be measured by a single radiologist using grayscale renal US and SWE. SWE measurements will be performed once prior to ESWL. A Philips EPİQ7 system (Philips Medical Systems, Bothell, WA) with a 1-5-MHz abdominal probe will be used for the procedure.
Who may be able to join
- Single Renal stones measured 6- 20 mm in maximal dimension.
- ESWL will be planned as the first line of treatment.
Who cannot join
- Patients with internal ureteral stent.
- ureteral stones.
- abnormal renal anatomies (pelvic kidney, horseshoe kidney, and rotational anomaly).
- active UTI at time of ESWL.
- coagulopathy .
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of medicine Beni Suef university hospital
Banī Suwayf, 62511
About this study
Official title: Evaluating Shear Wave Elastography as a Predictor of Extracorporeal Shock Wave Lithotripsy Outcomes and Stone Composition in Children "A Prospective Study"
This prospective study aims to evaluate the role of shear wave elastography (SWE) as a non-invasive and radiation-free tool for predicting the success of extracorporeal shock wave lithotripsy (ESWL) in pediatric patients with renal stones. Currently, computed tomography (CT)-derived Hounsfield units (HU) are used to estimate stone hardness; however, repeated radiation exposure is a concern in children. SWE may provide an alternative method by assessing stone stiffness using ultrasound.
Pediatric patients under 18 years with renal stones (6-20 mm) scheduled for ESWL will be included. SWE measurements will be performed prior to treatment, and patients will be followed for 3 months to assess treatment outcomes. The primary outcome is ESWL success, while secondary outcomes include correlation between SWE and HU, number of ESWL sessions required, prediction of stone composition, and assessment of the relationship between SWE measurements and stone composition.
This study seeks to determine whether SWE can serve as a reliable predictor of ESWL outcomes, correlate with stone composition, and reduce the need for radiation-based imaging in children.
- Conditions
- Pediatric Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Patients Undergoing ESWL | Pediatric patients (<18 years) with renal stones (6-20 mm) undergoing extracorporeal shock wave lithotripsy (ESWL). All patients will undergo baseline shear wave elastography (SWE) assessment prior to treatment. Patients will be followed for 3 months to evaluate ESWL success and its correlation with SWE measurements, Hounsfield units (HU), and stone composition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ESWL Success Rate
Treatment success defined as absence of stone fragments or presence of clinically insignificant residual fragments ≤2 mm on imaging, without symptoms, obstruction, or urinary tract infection.
Measured: 3 months with maximum 3 sessions ESWL
Secondary outcomes (1)
Secondary Outcomes Related to SWE and ESWL
Assessment of secondary outcomes including:
- correlation between shear wave elastography (SWE) values and CT-derived Hounsfield units (HU).
- Correlation between SWE and stone composition.
Measured: Up to 3 months after ESWL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start2 Dec 2025
- Primary completion1 May 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdallah, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506031
- Sponsor's protocol ID
- FMBSUREC/02122025/Badawy
- Acronym
- SWE-ESWL
- Status last verified
- Sep 2026
- First submitted
- 24 Mar 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Shear Wave Elastography as a Predictor of Extracorporeal Shock Wave Lithotripsy Outcomes and Stone Composition in Children "A Prospective Study"
- ClinicalTrials.gov ID
- NCT07506031
- Acronym / sponsor ID
- SWE-ESWL / FMBSUREC/02122025/Badawy
- Conditions
- Pediatric Urolithiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective study aims to evaluate the role of shear wave elastography (SWE) as a non-invasive and radiation-free tool for predicting the success of extracorporeal shock wave lithotripsy (ESWL) in pediatric patients with renal stones. Currently, computed tomography (CT)-derived Hounsfield units (HU) are used to estimate stone hardness; however, repeated radiation exposure is a concern in children. SWE may provide an alternative method by assessing stone stiffness using ultrasound.
Pediatric patients under 18 years with renal stones (6-20 mm) scheduled for ESWL will be included. SWE measurements will be performed prior to treatment, and patients will be followed for 3 months to assess treatment outcomes. The primary outcome is ESWL success, while secondary outcomes include correlation between SWE and HU, number of ESWL sessions required, prediction of stone composition, and assessment of the relationship between SWE measurements and stone composition.
This study seeks to determine whether SWE can serve as a reliable predictor of ESWL outcomes, correlate with stone composition, and reduce the need for radiation-based imaging in children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Patients Undergoing ESWL | – | –Pediatric patients (<18 years) with renal stones (6-20 mm) undergoing extracorporeal shock wave lithotripsy (ESWL). All patients will undergo baseline shear wave elastography (SWE) assessment prior to treatment. Patients will be followed for 3 months to evaluate ESWL success and its correlation with SWE measurements, Hounsfield units (HU), and stone composition. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients under 18 years of age diagnosed with renal stones measuring 6-20 mm and scheduled for extracorporeal shock wave lithotripsy (ESWL). Patients will be recruited from the outpatient clinic and followed for 3 months. Proper history, examination and basic laboratory investigations (CBC, coagulation profile, kidney and Liver functions, urine analysis and urine culture and sensitivity) will be performed for all participants. Low dose CTUT will be performed as usual for all patient to record stone location, size (maximum longitudinal and transverse dimensions), and HU. Renal stone elastography values will be measured by a single radiologist using grayscale renal US and SWE. SWE measurements will be performed once prior to ESWL. A Philips EPİQ7 system (Philips Medical Systems, Bothell, WA) with a 1-5-MHz abdominal probe will be used for the procedure.
Key inclusion criteria (2 listed)
Key exclusion criteria (6 listed)
- Patients with internal ureteral stent.
- ureteral stones.
- abnormal renal anatomies (pelvic kidney, horseshoe kidney, and rotational anomaly).
- active UTI at time of ESWL.
- coagulopathy .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ESWL Success Rate
Time frame: 3 months with maximum 3 sessions ESWL
Treatment success defined as absence of stone fragments or presence of clinically insignificant residual fragments ≤2 mm on imaging, without symptoms, obstruction, or urinary tract infection.
1 secondary outcome
Secondary Outcomes Related to SWE and ESWL
Time frame: Up to 3 months after ESWL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Urolithiasis, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ESWL Success Rate (time frame: 3 months with maximum 3 sessions ESWL). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.