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
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Ureteroscopy Versus Mini- Percutaneous Nephrolithotomy in Management of Pediatric Renal Stones Less Than 2 cm: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07870200
- Acronym / sponsor ID
- KFSIRB200-1163
- Conditions
- Renal Stone, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Elsayed Abdelhalim ElsayedUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 13 Oct 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A :Flexible ureteroscope group | Active comparator | Procedure: Group A :Flexible ureteroscope groupFlexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy |
| Group B: Mini perc group | Active comparator | Procedure: Group B : Mini perc groupMini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- pediatric patients <18 years old (according to American Academy of Pediatrics (AAP)
- Solitary renal with a size ranging from 1 to 2 cm .
Key exclusion criteria (7 listed)
- involved multiple or very small/large stones,
- adult over 18 years old,
- BMI > 40 kg/m²,
- bleeding disorders,
- congenital renal 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 |
|---|---|---|
| Group A :Flexible ureteroscope groupFlexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy | Procedure or surgery | Group A :Flexible ureteroscope group |
| Group B : Mini perc groupMini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set. | Procedure or surgery | Group B: Mini perc group |
Primary outcome
stone free rate
Time frame: Six weeks from primary procedure
1 secondary outcome
Post operative complication
Time frame: Up to 48 houra
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 15 Oct 2026.
Related trials for Renal Stone
Not yet recruiting
Automated Versus Manual Irrigation During Flexible Ureteroscopy
Renal Stone Disease
Not yet recruiting
Optimal Intrarenal Pressure During Flexible Ureteroscopy
Renal Stone Disease
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
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 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.
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 7 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 15 Oct 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 (time frame: Six weeks from primary 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 15 Oct 2026.