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.
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.
Ahmed Yehia Abdelaziz Mohammed, Professor of urology contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo university hospitals
Cairo
Faculty of Medicine - Cairo University, +20223647545, website@kasralainy.edu.eg
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 .
- Conditions
- Stones, Kidney, Ureter Stones
- 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 group | Role | What they receive |
|---|---|---|
| Using FANS | Active comparator | After 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 UAS | Active comparator | The 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.
• 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.
- First posted22 Jul 2025
- Study start1 Jun 2025
- Primary completion1 Mar 2026
- Study completion3 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stones, KidneyStudies 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
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yosseif elhousseiny ammar ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yosseif elhousseiny ammar ahmed, Cairo University
- Investigators
- Ahmed Yehia Abdelaziz Mohammed, Professor of urology, Principal investigator, Cairo University
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