NCT07763743

Brief Summary

Mini-percutaneous nephrolithotomy (mini-PCNL) and retrograde intrarenal surgery (RIRS) are both effective treatment modalities for renal calculi measuring up to 2.5 cm in pediatric patients, demonstrating similar efficacy and complication profiles. Suction has emerged as a potentially transformative adjunct in both percutaneous nephrolithotomy (PCNL) and RIRS. Recent studies evaluating various suction mechanisms during RIRS and mini-PCNL have demonstrated multiple benefits, including reduced operative time, higher stone-free rates (SFR), decreased intrarenal pressure (IRP) and temperature, as well as enhanced intraoperative visualization. Both FANS-UAS in RIRS and VAAS in Mini-PCNL have shown promising outcomes in the pediatric population. Taken together, these findings suggest that suction-assisted technologies whether in RIRS or Mini-PCNL enhance both efficacy and safety in pediatric stone management.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Jun 2026Jun 2027

Study Start

First participant enrolled

June 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2027

Last Updated

August 13, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

August 9, 2026

Last Update Submit

August 10, 2026

Conditions

Pediatric Renal Stones

Outcome Measures

Primary Outcomes (1)

  • Management of pediatric renal stones

    To compare stone-free rate (SFR) at 1 month after the procedure between RIRS using FURS-UAS and mini-PCNL using VASS in pediatric patients with renal stones 1-2.5 cm

    6 months

Study Arms (2)

Group A(Flexible Ureteroscopy with Flexible Navigable Suction Ureteral Access Sheath )

ACTIVE COMPARATOR

About 36 pediatric patients suffering from Renal Stones 1- 2.5 cm will be treated by Flexible Ureteroscopy with Flexible Navigable Suction Ureteral Access Sheath

Procedure: Flexible Ureteroscopy

Group B(Mini-Percutaneous Nephrolithotomy with Vacuum-Assisted Access Sheath )

ACTIVE COMPARATOR

About 36 pediatric patients suffering from Renal Stones 1- 2.5 cm will be treated by Mini-Percutaneous Nephrolithotomy with Vacuum-Assisted Access Sheath

Procedure: Flexible Ureteroscopy

Interventions

Flexible UreteroscopyPROCEDURE

To compare the efficacy and safety of flexible ureteroscopy using a flexible and navigable suction ureteral access sheath (FANS-UAS) versus mini-percutaneous nephrolithotomy (Mini-PCNL) using a vacuum-assisted access sheath (VAAS) in the management of pediatric renal stones 1-2.5 cm

Also known as: Mini-Percutaneous Nephrolithotomy
Group A(Flexible Ureteroscopy with Flexible Navigable Suction Ureteral Access Sheath )Group B(Mini-Percutaneous Nephrolithotomy with Vacuum-Assisted Access Sheath )

Eligibility Criteria

Age1 Year - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- Renal stone burden 1- 2.5 cm confirmed by imaging (CT or ultrasound).

You may not qualify if:

  • Patients who refuse to participate in the study.
  • Untreated Urinary tract infection (UTI) proved by urine culture and sensitivity.
  • Uncorrected coagulopathy.
  • Anatomical anomalies or ureteral stricture precluding either surgical approach.
  • Previous surgical intervention on the same kidney.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, Abbasia, Egypt

RECRUITING

Study Officials

  • Youssef Mahmoud kotb, Professor

    Urology Department, Faculty of Medicine, Ain Shams University

    STUDY CHAIR

Central Study Contacts

Mohamed Ramadan Mohamed Ramadan, MSc

CONTACT

+201005229645DR.MohamedRamadan@med.asu.edu.eg

Mohamed kotb Ahmed, professor

CONTACT

m.kotb@med.asu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer at Urology Department, Faculty of Medicine

Study Record Dates

First Submitted

August 9, 2026

First Posted

August 13, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 10, 2027

Last Updated

August 13, 2026

Record last verified: 2026-06

Locations

EG(1)