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Stones, KidneyNCT07076589

A Comparative Study Between the Usage of Flexible and Navigable Suction Ureteral Access Sheath Versus Traditional Access Sheath in Retrograde Intrarenal Surgeries

A study testing FURS in people with Stones, Kidney and Ureter Stones, run by Yosseif elhousseiny ammar ahmed at 1 site in Egypt.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

A comparative study between the Usage of Flexible and Navigable Suction Ureteral Access Sheath (FANS) versus Traditional Access sheath in RIRS : Randomized controlled trial . Read more about this study

Who is it for?
Ages 14 years and older
Conditions the study is for
Stones, Kidney, Ureter Stones
What is being tested?
FURS
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteEgypt
Study dates
1 Jun 2025to 3 Mar 2026
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 14 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age ≥14 years old in patients not known to have stone forming medical conditions.
  • Renal stones diameter of ≤2 cm confirmed by CT with all types of configurations (branching \& non-branching).
  • Non - recurrent cases with no history of previous open renal surgeries or PCNL with normal renal anatomy.
  • Patients with non - infected urine analysis.

Who cannot join

  • Patients with abnormal urinary tract anatomy (such as horseshoe kidney or ileal conduit).
  • Patients with medical conditions promoting stone formation (hyperparathyroidism - gout).
  • Patients with history of stones on the same side with previous open surgical intervention or PCNL .
  • Patients with e-GFR < 60 ml / min.
  • Patients with uncontrolled urinary tract infection.
  • Patients with health or other factors that are absolute contraindications to RIRS.
  • Patients who are unable to understand or complete trial documentation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yosseif Ammar, MBBCH contact

201226912630

yosefelhousseiny@gmail.com

Ahmed Yehia Abdelaziz Mohammed, Professor of urology contact

201229793766

mailto:dr_ahmedyehia81@yahoo.com

Egypt1 site, 1 recruiting
  • Cairo university hospitals

    Cairo

    Faculty of Medicine - Cairo University, +20223647545, website@kasralainy.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: A Comparative Study Between the Usage of Flexible and Navigable Suction Ureteral Access Sheath (FANS) Versus Traditional Access Sheath in RIRS : Randomized Controlled Trial

A comparative study between the Usage of Flexible and Navigable Suction Ureteral Access Sheath (FANS) versus Traditional Access sheath in RIRS : Randomized controlled trial .

Read the detailed description

Urinary calculus is a worldwide urological disease, with a prevalence ranging from 1% to 13% in different regions . Currently, the main therapeutic methods beyond conservative treatment for renal calculi include extracorporeal shock wave lithotripsy (ESWL) and minimally invasive endoscopic surgical methods, including percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS). Treatment plans depend on the characteristics of calculi, patient factors, surgeon experience and the condition of medical centers .

Technological advancements in RIRS have been numerous in recent years, with the introduction of single-use flexible ureteroscopes and higher-power lasers being the most notable. High intrarenal pressure (IRP) can lead to pyelovenous backflow and infection from transient bacteraemia, particularly during laser lithotripsy. Another major concern is the retention of residual fragments (RFs), which are pieces that are hidden from view because of the snow-globe effect .

Therefore, in order to facilitate the clearance of RF and enhance the overall performance of RIRS, a variety of adjuncts have been developed, including pressure sensors to regulate IRP, a direct in-scope vacuum technique to aspirate dust, and stone retrieval devices that utilize suction technologies .

These objectives are all designed to achieve the triumvirate of successful RIRS: a high stone-free rate (SFR), minimal ancillary interventions, and minimal complications-the ultimate goal of all RIRS surgeons .

The ureteral access sheath (UAS) has been used in RIRS to reduce IRP and hence infectious complications, as well as to improve drainage, stone clearance, and intraoperative vision, thus shortening operative time. However, there still remains some debate over the ideal UAS size - too large risks injuring the ureteral mucosa and causing ischaemia, while too small defeats its purpose of improving drainage .

The addition of suction to a traditional UAS resulted in the conception of suction ureteral access sheath (SUAS). As demonstrated in clinical studies, the SUAS has the potential to reduce intrarenal temperature and pressure, thus reducing infectious complications and improving SFR .

Nevertheless, the SUAS continues to exhibit certain constraints . If it is positioned below the uretero-pelvic junction (UPJ), as is the case with the traditional UAS, the application of suction results in the collapse of the proximal ureteral mucosa. This reduces the calibre of the narrow UPJ and impedes the aspiration of RF by acting as a functional valve to block the opening of the UAS. Despite being positioned across the UPJ, it is incapable of overcoming acute angles or reaching distant calyces to facilitate the complete aspiration of particulate that has settled in dependent calyces .

A flexible-tip SUAS, also known as the flexible and navigable suction UAS (FANS), was developed as a natural evolution. This SUAS could be navigated using the flexible scope. FANS can be securely maneuvered into individual calyces under fluoroscopic guidance to remove fragments and dust more thoroughly and targeted through suctioning .

Being tested
FURS
Medical subject headings
Kidney Calculi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FURSProcedure or surgery

    FURS using traditional UAS \& FANS

Study groups in NCT07076589
Study groupRoleWhat they receive
Using FANSActive comparatorAfter the successful induction of anesthesia, the lithotomy position will be adopted. Ureteroscopy will be used with the aid of a safety guidewire to evaluate the condition of the ureter. The serial dilation of the ureter using ureteral dilators up to 14 Fr . The FANS will be then inserted into the ureter under the guidance of the safety guidewire. The FANS tip will be positioned in the renal pelvis or calyces near the location of the stone. The FANS will be connected to a vacuum device, and the negative pressure will be applied. The actual intraoperative negative pressure value will be adjusted by the urologist through a pressure adjustment vent as needed. The irrigation volume was set using peristaltic pumps. Lithotripsy will be conducted using the holmium: yttrium aluminum garnet laser applying the dusting technique of laser lithotripsy. During lithotripsy, the FANS will allow us to retrieve most of the fragmented stone particles by application of the suction pressure. All cases w
Receives: Procedure: FURS
Using traditional UASActive comparatorThe method of anesthesia, patient positioning, ureteral dilation, and lithotripsy were the same as those used in the FANS group. For the traditional UAS group, the end of the UAS will be positioned underneath the ureteropelvic junction (UPJ). The irrigation volume is applied using peristaltic pumps. The dusting technique of laser lithotripsy will be applied to the stones. All cases will be stented using JJ stents with the suitable size.
Receives: Procedure: FURS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. • Stone-free rate (SFR).

    Measured: 12 weeks postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2025
  2. Study start1 Jun 2025
  3. Primary completion1 Mar 2026
  4. Study completion3 Mar 2026 (estimated)

Resources

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
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07076589
Sponsor's protocol ID
MS-210-2025
Status last verified
Mar 2026
First submitted
13 Jun 2025
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all collected IPD, all IPD that underlie results in a publication

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