Kidney CalculiNCT07780409
Flexible Ureteroscopy for Large Renal Stones in Children
A study testing Flexible Ureteroscopic Stone Disintegration in people with Kidney Calculi, run by Cairo University at 1 site in Egypt.
Trial summary
This prospective single-arm interventional study evaluated the efficacy and safety of flexible ureteroscopy for the treatment of large renal stones measuring 2 cm or more in pediatric patients. Read more about this study
- Who is it for?
- Ages 0 to 13 years
- Conditions the study is for
- Kidney Calculi
- What is being tested?
- Flexible Ureteroscopic Stone Disintegration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 1 Feb 2026
- 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 0 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients diagnosed with renal stones.
- Renal stone size ≥2 cm.
- Age younger than 14 years.
Who cannot join
- Uncontrolled urinary tract infection.
- Impaired renal function.
- Abnormal anatomical location of the kidney.
- Congenital renal or ureteric anomalies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flexible Ureteroscopic Stone Disintegration in Pediatric Age Group for Large Renal Stones (≥2 cm)
This prospective single-arm interventional study evaluated the efficacy and safety of flexible ureteroscopy for the treatment of large renal stones measuring 2 cm or more in pediatric patients. All enrolled participants underwent flexible ureteroscopic stone disintegration using a single-use flexible ureteroscope and Holmium laser lithotripsy. The study was designed to assess whether this minimally invasive approach could provide effective stone clearance with acceptable perioperative safety in children with large renal stones.
- Conditions
- Kidney Calculi
- Being tested
- Flexible Ureteroscopic Stone Disintegration
- Keywords
- Pediatric Urolithiasis, Renal Stones, Large Renal Stones, Flexible Ureteroscopy, Flexible Ureterorenoscopy, Single-Use Flexible Ureteroscope, Laser Lithotripsy, Holmium:YAG Laser
- Medical subject headings
- Kidney Calculi, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible Ureteroscopic Stone DisintegrationProcedure or surgery
Flexible ureteroscopy was performed using a 7.5-Fr single-use flexible ureteroscope. Renal stones were fragmented with a Holmium:YAG laser. A ureteral access sheath was used when feasible, and a double-J ureteral stent was placed at the end of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Flexible Ureteroscopic Stone Disintegration | Experimental | Pediatric patients with large renal stones (≥2 cm) underwent flexible ureteroscopic stone disintegration using a 7.5-Fr single-use flexible ureteroscope and Holmium:YAG laser lithotripsy. A ureteral access sheath was used when feasible, and a double-J ureteral stent was inserted at the end of the procedure. Receives: Procedure: Flexible Ureteroscopic Stone Disintegration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-Free Rate After Flexible Ureteroscopic Stone Disintegration
Stone-free status was assessed by computed tomography of the urinary tract (CTUT) after flexible ureteroscopic stone disintegration. The proportion of participants meeting the study-defined criteria for stone-free status was recorded.
Measured: 1 month after the procedure
Secondary outcomes (1)
Operative Time
Duration of the flexible ureteroscopic procedure was recorded for each participant.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Aug 2025
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- All enrolled pediatric patients with large renal stones underwent flexible ureteroscopic stone disintegration using a single-use flexible ureteroscope and Holmium:YAG laser.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mohamed Hosny, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780409
- Sponsor's protocol ID
- FMASU MS 391/2025
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Ureteroscopic Stone Disintegration in Pediatric Age Group for Large Renal Stones (≥2 cm)
- ClinicalTrials.gov ID
- NCT07780409
- Acronym / sponsor ID
- FMASU MS 391/2025
- Conditions
- Kidney Calculi
- Keywords
- Pediatric Urolithiasis, Renal Stones, Large Renal Stones, Flexible Ureteroscopy, Flexible Ureterorenoscopy, Single-Use Flexible Ureteroscope, Laser Lithotripsy, Holmium:YAG Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 21 Aug 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 single-arm interventional study evaluated the efficacy and safety of flexible ureteroscopy for the treatment of large renal stones measuring 2 cm or more in pediatric patients. All enrolled participants underwent flexible ureteroscopic stone disintegration using a single-use flexible ureteroscope and Holmium laser lithotripsy. The study was designed to assess whether this minimally invasive approach could provide effective stone clearance with acceptable perioperative safety in children with large renal stones.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled pediatric patients with large renal stones underwent flexible ureteroscopic stone disintegration using a single-use flexible ureteroscope and Holmium:YAG laser.
| Arm | Type | Receives |
|---|---|---|
| Flexible Ureteroscopic Stone Disintegration | Experimental | Procedure: Flexible Ureteroscopic Stone DisintegrationPediatric patients with large renal stones (≥2 cm) underwent flexible ureteroscopic stone disintegration using a 7.5-Fr single-use flexible ureteroscope and Holmium:YAG laser lithotripsy. A ureteral access sheath was used when feasible, and a double-J ureteral stent was inserted at the end of the procedure. |
Who may qualify
- Ages
- 0 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients diagnosed with renal stones.
- Renal stone size ≥2 cm.
- Age younger than 14 years.
Key exclusion criteria (4 listed)
- Uncontrolled urinary tract infection.
- Impaired renal function.
- Abnormal anatomical location of the kidney.
- Congenital renal or ureteric anomalies.
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 Ureteroscopic Stone DisintegrationFlexible ureteroscopy was performed using a 7.5-Fr single-use flexible ureteroscope. Renal stones were fragmented with a Holmium:YAG laser. A ureteral access sheath was used when feasible, and a double-J ureteral stent was placed at the end of the procedure. | Procedure or surgery | Flexible Ureteroscopic Stone Disintegration |
Primary outcome
Stone-Free Rate After Flexible Ureteroscopic Stone Disintegration
Time frame: 1 month after the procedure
Stone-free status was assessed by computed tomography of the urinary tract (CTUT) after flexible ureteroscopic stone disintegration. The proportion of participants meeting the study-defined criteria for stone-free status was recorded.
1 secondary outcome
Operative Time
Time frame: Intraoperatively
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 21 Aug 2026.
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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 Ureteroscopic Stone Disintegration in people with Kidney Calculi, run by Cairo 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 3 inclusion and 4 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 21 Aug 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?
Stone-Free Rate After Flexible Ureteroscopic Stone Disintegration (time frame: 1 month after the procedure). 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 21 Aug 2026.