Renal StonesRIRS pediatricNCT07089394
Retrograde Intrarenal Surgery for Renal Stones in Pediatrics: A Prospective Analysis of Feasibility and Outcomes.
A study testing flexible urs in people with Renal Stones and Pediatric Renal Stones, run by Al-Azhar University at 1 site in Egypt.
Trial summary
it is an interventional single arm study for treating pediatric renal stones≤2cm by FURS and Holmium laser fragmentation.pediatric groups is benig compared for stone free rate, complication rate , success rate. 3 groups of children . group 1 up to 6 years, group 2 from 7 to 12 years , group 3 from 13 to 18 years Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Renal Stones, Pediatric Renal Stones
- What is being tested?
- flexible urs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 20 May 2025
- Phase
- Interventional
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- pediatric renal stones ≤2cm indicated for treatment
Who cannot join
- congenital urinary tract anomalies, coagulation disorders, active uti,distal ureteric obstruction, bigger stone size
Trial locations and contacts
1 site in 1 country.
Egypt1 site
AlAzhar university hospitals/Urology department
Cairo, Cairo Governorate, 00202
About this study
it is an interventional single arm study for treating pediatric renal stones≤2cm by FURS and Holmium laser fragmentation.pediatric groups is benig compared for stone free rate, complication rate , success rate. 3 groups of children . group 1 up to 6 years, group 2 from 7 to 12 years , group 3 from 13 to 18 years
- Conditions
- Renal Stones, Pediatric Renal Stones
- Being tested
- flexible urs
- Keywords
- pediatric, renal stones, flexible ureteroscopy, holmium laser
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flexible ursProcedure or surgery
Also called RIRS, FURS
treating pediatric renal stones with flexible urs+holmium laser fragmentation
| Study group | Role | What they receive |
|---|---|---|
| pediatric patients presented with ≤2cm renal stones within 2 years from jan 2023 to jan 2025 | Other | treatment of pediatric renal stones ≤2cmwith flexible URS +Holmium laser fragmentation Receives: Procedure: flexible urs |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate
stone free rate as proved by ctut ,defined as fragments ≤2 mm fragment
Measured: within 2 months after intervention
Secondary outcomes (1)
complication rate among all groups
complication rate over all and in each pediatric group in comparative analysis
Measured: intra, post operative, untill stent removal or within 2 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Jan 2023
- Primary completion24 Apr 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StonesStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Gouda, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089394
- Sponsor's protocol ID
- 7603
- Acronym
- RIRS pediatric
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results and publication
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrograde Intrarenal Surgery for Renal Stones in Pediatrics: A Prospective Analysis of Feasibility and Outcomes.
- ClinicalTrials.gov ID
- NCT07089394
- Acronym / sponsor ID
- RIRS pediatric / 7603
- Conditions
- Renal Stones, Pediatric Renal Stones
- Keywords
- pediatric, renal stones, flexible ureteroscopy, holmium laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 28 Jul 2025 (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.
it is an interventional single arm study for treating pediatric renal stones≤2cm by FURS and Holmium laser fragmentation.pediatric groups is benig compared for stone free rate, complication rate , success rate. 3 groups of children . group 1 up to 6 years, group 2 from 7 to 12 years , group 3 from 13 to 18 years
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric patients presented with ≤2cm renal stones within 2 years from jan 2023 to jan 2025 | Other | Procedure: flexible urstreatment of pediatric renal stones ≤2cmwith flexible URS +Holmium laser fragmentation |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- pediatric renal stones ≤2cm indicated for treatment
Key exclusion criteria (1 listed)
- congenital urinary tract anomalies, coagulation disorders, active uti,distal ureteric obstruction, bigger stone size
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flexible ursAlso: RIRS, FURStreating pediatric renal stones with flexible urs+holmium laser fragmentation | Procedure or surgery | pediatric patients presented with ≤2cm renal stones within 2 years from jan 2023 to jan 2025 |
Primary outcome
stone free rate
Time frame: within 2 months after intervention
stone free rate as proved by ctut ,defined as fragments ≤2 mm fragment
1 secondary outcome
complication rate among all groups
Time frame: intra, post operative, untill stent removal or within 2 months after intervention
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 28 Jul 2025.
- Individual participant dataSharing planned: Yes. IPD used in the results and publication
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Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
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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?
A study testing flexible urs in people with Renal Stones and Pediatric Renal Stones, run by Al-Azhar 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 1 inclusion and 1 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 28 Jul 2025. 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?
stone free rate (time frame: within 2 months after intervention). 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 28 Jul 2025.