NCT07089394

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2025

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

2.3 years

First QC Date

July 21, 2025

Last Update Submit

July 21, 2025

Conditions

Renal StonesPediatric Renal Stones

Keywords

pediatricrenal stonesflexible ureteroscopyholmium laser

Outcome Measures

Primary Outcomes (1)

  • stone free rate

    stone free rate as proved by ctut ,defined as fragments ≤2 mm fragment

    within 2 months after intervention

Secondary Outcomes (1)

  • complication rate among all groups

    intra, post operative, untill stent removal or within 2 months after intervention

Study Arms (1)

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

Procedure: flexible urs

Interventions

flexible ursPROCEDURE

treating pediatric renal stones with flexible urs+holmium laser fragmentation

Also known as: RIRS, FURS
pediatric patients presented with ≤2cm renal stones within 2 years from jan 2023 to jan 2025

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • pediatric renal stones ≤2cm indicated for treatment

You may not qualify if:

  • congenital urinary tract anomalies, coagulation disorders, active uti,distal ureteric obstruction, bigger stone size

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AlAzhar university hospitals/Urology department

Cairo, Cairo Governorate, 00202, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
urology assistant lecturer

Study Record Dates

First Submitted

July 21, 2025

First Posted

July 28, 2025

Study Start

January 1, 2023

Primary Completion

April 24, 2025

Study Completion

May 20, 2025

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

IPD used in the results and publication

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
2025 till 2026

Locations

EG(1)