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Clinical Trials/NCT07089394
NCT07089394CompletedNot Applicable

Retrograde Intrarenal Surgery for Renal Stones in Pediatrics: A Prospective Analysis of Feasibility and Outcomes.

Al-Azhar University1 site in 1 country50 target enrollmentStarted: January 1, 2023Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
stone free rate
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •pediatric renal stones ≤2cm indicated for treatment

Exclusion Criteria

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

Arms & Interventions

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

Intervention: flexible urs (Procedure)

Outcomes

Primary Outcomes

stone free rate

Time Frame: within 2 months after intervention

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

Secondary Outcomes

  • complication rate among all groups(intra, post operative, untill stent removal or within 2 months after intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Emad Gouda

urology assistant lecturer

Al-Azhar University

Study Sites (1)

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