Renal StoneNCT07870200
Flexible Ureteroscopy Versus Mini- Percutaneous Nephrolithotomy in Management of Pediatric Renal Stones Less Than 2 cm
A study testing Group A :Flexible ureteroscope group and Group B : Mini perc group in people with Renal Stone and Pediatric, run by Elsayed Abdelhalim Elsayed at 1 site in Egypt.
Trial summary
This single-center, prospective, two-arm randomized controlled trial included 58 patients younger than 18 years who were allocated 1:1 to Mini-PCNL or FURS between June 2023 and December 2024. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Stone, Pediatric
- What is being tested?
- Group A :Flexible ureteroscope group and Group B : Mini perc group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Dec 2024
- Phase
- Interventional
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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- pediatric patients <18 years old (according to American Academy of Pediatrics (AAP)
- Solitary renal with a size ranging from 1 to 2 cm .
Who cannot join
- involved multiple or very small/large stones,
- adult over 18 years old,
- BMI > 40 kg/m²,
- bleeding disorders,
- congenital renal anomalies,
- distal obstruction, or
- musculoskeletal deformities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flexible Ureteroscopy Versus Mini- Percutaneous Nephrolithotomy in Management of Pediatric Renal Stones Less Than 2 cm: a Prospective Randomized Study
This single-center, prospective, two-arm randomized controlled trial included 58 patients younger than 18 years who were allocated 1:1 to Mini-PCNL or FURS between June 2023 and December 2024. The primary outcome was the six-week stone-free rate (SFR), defined as complete absence of residual fragments on postoperative imaging. Secondary outcomes included operative time, fluoroscopy time, hospital stay, auxiliary procedures, hemoglobin measurements, and postoperative complications.
- Conditions
- Renal Stone, Pediatric
- Being tested
- Group A :Flexible ureteroscope group, Group B : Mini perc group
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A :Flexible ureteroscope groupProcedure or surgery
Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy
Group B : Mini perc groupProcedure or surgery
Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set.
| Study group | Role | What they receive |
|---|---|---|
| Group A :Flexible ureteroscope group | Active comparator | Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy Receives: Procedure: Group A :Flexible ureteroscope group |
| Group B: Mini perc group | Active comparator | Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set. Receives: Procedure: Group B : Mini perc group |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate
Measured: Six weeks from primary procedure
Secondary outcomes (1)
Post operative complication
Measured: Up to 48 houra
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Jun 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StoneStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsayed Abdelhalim Elsayed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elsayed Abdelhalim Elsayed, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870200
- Sponsor's protocol ID
- KFSIRB200-1163
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No