Standard Versus Flexible and Navigable Suction Ureteral Access Sheath in Pediatric Flexible Ureterorenoscopy for Renal Stones < 2 cm

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorTanta University

About this trial

This randomized controlled trial aims to compare the efficacy and safety of a Flexible and Navigable Suction Ureteral Access Sheath (FANS) versus a standard ureteral access sheath during flexible ureterorenoscopy (FURS) in pediatric patients with renal stones less than 2 cm. The study will evaluate stone-free rates. operative time. intraoperative parameters. operative and postoperative complication and the need for any auxiliary procedures. Sixty pediatric patients will be randomly allocated into two equal groups and treated at the Urology Department, Tanta University.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pediatric patients (age ≤ 18 years)

Patients with renal stones less than 2 cm

Indicated for flexible ureterorenoscopy

Fit for general anesthesia

Disqualifiers

Stones larger than 2 cm

Active urinary tract infection

Congenital urinary tract anomalies affecting access

Previous ureteral surgery affecting the ureter

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Ureteral Access Sheath (Boston Scientific).

    Device

    Standard UAS (Length: 28-35 cm, Size: 10/12 Fr or 9.5/11.5 Fr)

  • Flexible and Navigable Suction UAS (ClearPetra).

    Device

    Suction evacuation ureteral access sheath (Length: 30-35 cm, Size: 10/12 Fr or 11/13 Fr) with terminal flexible end

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group A: Standard UASActive comparator 1 intervention
Group B: Group B: Suction UAS (FAAN)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Stone-free rate (SFR)

Absence of residual fragments or presence of clinically insignificant residual fragments measuring \< 3 mm, assessed by postoperative CT scan.

Time frame
1 month postoperatively

Secondary outcomes

1

Operative time

Time frame
Intraoperatively . from insertion of sheath
2

Intraoperative visibility and ease of access

Intraoperative visibility and ease of access using scale (good-moderate-poor)

Time frame
intraoperatively
3

Intraoperative complications

Time frame
intraoperatively
4

Postoperative complications

Postoperative complications (according to Clavien-Dindo classification).

Time frame
up to 30 days postoperatively

Other outcomes

Sponsors and contacts

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