Actively Recruiting
A Comparative Study Between the Flexible and Navigable Suction Ureteral Access Sheath Versus Traditional Access Sheath in Retrograde Intrarenal Surgery
Led by Yosseif elhousseiny ammar ahmed · Updated on 2026-03-10
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the use of a Flexible and Navigable Suction Ureteral Access Sheath (FANS) with a traditional ureteral access sheath during retrograde intrarenal surgery (RIRS) for kidney and ureter stones. This randomized controlled trial aims to evaluate which method better aids in stone clearance while minimizing complications related to intrarenal pressure and residual stone fragments. The study addresses ongoing challenges in RIRS, such as managing intrarenal pressure and improving stone-free rates through technological advancements in access sheath design. The study involves two groups: one using FANS and the other using a traditional ureteral access sheath (UAS). After anesthesia, patients are positioned for surgery and their ureters are dilated. In the FANS group, a flexible suction sheath is navigated into the kidney to aspirate stone fragments during laser lithotripsy, while the traditional UAS group uses a fixed sheath positioned below the ureteropelvic junction. Both groups undergo laser treatment with irrigation pumps, and JJ stents are placed after the procedure. Participants will be monitored for stone clearance using imaging 12 weeks after surgery to measure the stone-free rate. The trial includes assessments of surgical effectiveness and potential complications related to ureteral access and stone removal. Patient health, urine infection status, and renal function are evaluated for eligibility, and the total duration of participation involves preoperative preparation, surgery, and follow-up assessments over several weeks.
CONDITIONS
Brief Title
A Comparative Study Between the Usage of Flexible and Navigable Suction Ureteral Access Sheath Versus Traditional Access Sheath in Retrograde Intrarenal Surgeries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 14 years or older
- Kidney stones 2 cm or smaller confirmed by CT with all configurations
- No previous open kidney surgery or percutaneous nephrolithotomy (PCNL) on the affected side
- Normal kidney anatomy
- No active urinary infection
You will not qualify if you...
- Abnormal urinary tract anatomy such as horseshoe kidney or ileal conduit
- Medical conditions that promote stone formation, like hyperparathyroidism or gout
- History of stones on the same side with prior open surgery or PCNL
- Kidney function with e-GFR less than 60 ml/min
- Uncontrolled urinary tract infection
- Any health or other factors that prevent safe retrograde intrarenal surgery
- Inability to understand or complete study documentation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo retrograde intrarenal surgery (RIRS) using either the flexible and navigable suction ureteral access sheath (FANS) or traditional ureteral access sheath (UAS) to remove kidney stones. The procedure involves anesthesia, ureteral dilation, laser lithotripsy with suction to clear stone fragments, and placement of a stent.
1 surgical procedure visit (in-person)
Duration - 12 weeks
Participants are monitored postoperatively to assess stone clearance and recovery, including evaluation of the stone-free rate at 12 weeks after surgery.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Cairo university hospitals
Cairo, Egypt
Actively Recruiting
Research Team
Y
Yosseif Ammar, MBBCH
A
Ahmed Yehia Abdelaziz Mohammed, Professor of urology
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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