ClinicalTrials.gg
Not yet recruitingNCT07689565FANS-UASUpdated Jul 8, 2026

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

An interventional study of Standard Ureteral Access Sheath (Boston Scientific). and Flexible and Navigable Suction UAS (ClearPetra). in Pediatric Urolithiasis, Kidney Stone and Nephrolithiasis, sponsored by Tanta University. Not yet recruiting at 1 site in Egypt. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
1 Year to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 56 studies in Kidney Calculi with a site in Egypt — 20 open to participants now, 22 under way, none of them phase 3. Kidney Calculi · Egypt.

Planned enrollment
41st of 51
60 · median 100
Started
2026
with 11 others
No phase
48 of 56
19 open now
Primary completion
2027-06
later than 17 of 21 live
Registered
51st of 56
by date
Lead sponsor
2 of 56
Tanta University

Among the 56 studies in Kidney Calculi with a site in Egypt, this one is the 41st largest by planned enrollment of the 51 interventional ones, is one of 12 that started in 2026, is one of 48 with no phase, reaches primary completion later than 17 of the 21 other live ones, and was the 51st registered.

By phase

56 studies; the count open now beside each. This study's row is marked.

No phasethis study48 · 19 open
Observational5 · 1 open
Phase 42 · 0 open
Phase 31 · 0 open

By the year they started

First in 2011; this study’s year is marked. 12 started in 2026.

Size and results

Median enrollment 100 across the 51 interventional studies, 100 across the 5 observational. Of the 24 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 56 studies in Kidney Calculi with a site in Egypt, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Pediatric Urolithiasis
  • Kidney Stone
  • Nephrolithiasis

Keywords

  • Flexible Ureterorenoscopy
  • Retrograde Intrarenal Surgery
  • Ureteral Access Sheath
  • Suction-Assisted Ureteroscopy
  • Pediatric Urology
04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Pediatric patients (age ≤ 18 years)
  2. Patients with renal stones less than 2 cm
  3. Indicated for flexible ureterorenoscopy
  4. Fit for general anesthesia
  5. obtained from parents or guardians

Exclusion criteria

Exclusion Criteria:

  1. Stones larger than 2 cm
  2. Active urinary tract infection
  3. Congenital urinary tract anomalies affecting access
  4. Previous ureteral surgery affecting the ureter
  5. Coagulopathy or unfit for surgery
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Group A: Standard UAS

    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.

    Device: Standard Ureteral Access Sheath (Boston Scientific).

  • Experimental
    Group B: Suction UAS (FAAN)

    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

    Device: Flexible and Navigable Suction UAS (ClearPetra).

Interventions

  • DeviceStandard Ureteral Access Sheath (Boston Scientific).

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

  • DeviceFlexible and Navigable Suction UAS (ClearPetra).

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

06

What researchers measure

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

  5. 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

    Time frame: up to 30 days postoperatively

  6. 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

    Time frame: From the day of surgery up to hospital discharge (estimated average of 3 days)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Jun 2027, 11 months later.

Of 183 non-industry interventional studies with no phase under Kidney Calculi, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 11 months is below that.

Counting every sponsor, half of 199 studies reached it within 26 months; a quarter within 12 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 30, 2026
First posted
Jul 8, 2026
StartEst.
Jun 30, 2026
Primary completionEst.
Jun 1, 2027
CompletionEst.
Jun 30, 2027
Last update
Jul 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07689565
Lead sponsor
Tanta University
Responsible party
Khaled Mostafa Saed Elmaradny (Resident of Urology, Damanhour Teaching Hospital, Egypt, Tanta University) — Principal investigator
First posted
Jul 8, 2026
Start date
Jun 30, 2026 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Jul 8, 2026

Study contacts

khaled Mostafa elmaradney, MD
Contact
khaledelmaradney@gmail.com
+201014508582
mohamed ebrahim elmaadawy, MD.PHD
Contact
mohamed.elmaadawy@med.tanta.edu.eg
+201060245430
salah abdelmnsef nagla, MD-PHD
study chair · Tanta unversity
osama mostafa elgamal, MD-PHD
study director · Tanta unversity
Mohamed ebrahim elmaadawy, MD-PHD
study director · Tanta unversity

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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