Pediatric UrolithiasisFANS-UASNCT07689565
Standard Versus Flexible and Navigable Suction Ureteral Access Sheath in Pediatric Flexible Ureterorenoscopy for Renal Stones < 2 cm
A study testing Standard Ureteral Access Sheath (Boston Scientific). and Flexible and Navigable Suction UAS (ClearPetra). in people with Pediatric Urolithiasis and Kidney Stone, run by Tanta University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Pediatric Urolithiasis, Kidney Stone, Nephrolithiasis
- What is being tested?
- Standard Ureteral Access Sheath (Boston Scientific). and Flexible and Navigable Suction UAS (ClearPetra).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2026to 30 Jun 2027
- Phase
- Interventional
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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients (age ≤ 18 years)
- Patients with renal stones less than 2 cm
- Indicated for flexible ureterorenoscopy
- Fit for general anesthesia
- Informed consent obtained from parents or guardians
Who cannot join
- Stones larger than 2 cm
- Active urinary tract infection
- Congenital urinary tract anomalies affecting access
- Previous ureteral surgery affecting the ureter
- Coagulopathy or unfit for surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Tanta University
Tanta, Gharbia Governorate, 31527
khaled mostafa elmaradney, MD, +201014508582, khaledelmaradney@gmail.com
alaa abdelsamd alshazly, MD, +201068576598, alaaabdelsamed0@gmail.com
About this study
Official title: Standard Versus Flexible and Navigable Suction Ureteral Access Sheath in Pediatric Flexible Ureterorenoscopy for Renal Stones < 2 cm : A Randomized Controlled Study
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.
Read the detailed description
Pediatric urolithiasis is an increasingly recognized condition associated with substantial morbidity and recurrence risk. Flexible ureterorenoscopy has become an established minimally invasive treatment option for renal stones smaller than 2 cm. The use of ureteral access sheaths facilitates repeated upper urinary tract access and may improve operative efficiency; however, concerns regarding ureteral trauma remain.
Recently developed suction-assisted ureteral access sheaths have been introduced to improve visibility, facilitate fragment evacuation, and reduce intrarenal pressure. Although promising results have been reported in adults, evidence in pediatric patients remains limited.
This prospective randomized controlled trial will compare a standard ureteral access sheath with a Flexible and Navigable Suction Ureteral Access Sheath (FANS) in pediatric patients undergoing flexible ureterorenoscopy for renal stones less than 2 cm.
- Conditions
- Pediatric Urolithiasis, Kidney Stone, Nephrolithiasis
- Being tested
- Standard Ureteral Access Sheath (Boston Scientific)., Flexible and Navigable Suction UAS (ClearPetra).
- Keywords
- Flexible Ureterorenoscopy, Retrograde Intrarenal Surgery, Ureteral Access Sheath, Suction-Assisted Ureteroscopy, Pediatric Urology
- Medical subject headings
- Kidney Calculi, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Group A: Standard UAS | Active comparator | Standard UAS (Length: 28-35 cm, Size: 10/12 Fr or 9.5/11.5 Fr) used during flexible ureteroscopic stone fragmentation using Holmium:YAG laser. Receives: Device: Standard Ureteral Access Sheath (Boston Scientific). |
| Group B: Suction UAS (FAAN) | Experimental | Suction evacuation ureteral access sheath (Length: 30-35 cm, Size: 10/12 Fr or 11/13 Fr) with terminal flexible end enabling continuous drainage and suction during laser stone fragmentation Receives: Device: Flexible and Navigable Suction UAS (ClearPetra). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free rate (SFR)
Absence of residual fragments or presence of clinically insignificant residual fragments measuring < 3 mm, assessed by postoperative CT scan.
Measured: 1 month postoperatively
Secondary outcomes (6)
Operative time
Measured: Intraoperatively . from insertion of sheath
Intraoperative visibility and ease of access
Intraoperative visibility and ease of access using scale (good-moderate-poor)
Measured: intraoperatively
Intraoperative complications
Measured: intraoperatively
Postoperative complications
Postoperative complications (according to Clavien-Dindo classification).
Measured: up to 30 days postoperatively
Need for auxiliary procedures.
This outcome measure will evaluate the requirement for additional interventions to achieve complete stone clearance or manage residual fragments. It will be assessed by recording the percentage of participants who require any secondary or ancillary surgical procedures (such as second-stage ureterorenoscopy, shock wave lithotripsy, or temporary stenting) within 30 days postoperatively
Measured: up to 30 days postoperatively
Length of hospital stay.
The duration of hospitalization will be calculated in days, from the date of the participant's admission/surgery until the actual date of discharge from the hospital
Measured: From the day of surgery up to hospital discharge (estimated average of 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start30 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric UrolithiasisStudies 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
- Model description
- Eligible pediatric patients will be randomly allocated into two equal parallel groups (1:1 ratio). Group A will undergo flexible ureterorenoscopy (FURS) using a standard ureteral access sheath (UAS), while Group B will undergo FURS using a flexible and navigable suction ureteral access sheath (FANS). Both groups will be followed up postoperatively to compare efficacy and safety outcomes.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Mostafa Saed Elmaradny, Tanta University
- Investigators
- salah abdelmnsef nagla, MD-PHD, Study chair, Tanta unversityosama mostafa elgamal, MD-PHD, Study director, Tanta unversityMohamed ebrahim elmaadawy, MD-PHD, Study director, Tanta unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689565
- Sponsor's protocol ID
- 36265MS60 / 5 / 26
- Acronym
- FANS-UAS
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No