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Not yet recruiting NCT06889051

Comparison of Flexible & Navigable Suction Ureteral Access Sheath vs. Antegrade Suction in Retrograde Flexible Ureteroscopy for Lower Calyceal Stones

No phase Interventional Nephrolithiasis Urolithiasis Endourology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Flexible & Navigable Suction Ureteral Access Sheath (FANS), Antegrade Suction via Percutaneous Nephrostomy.
Who it may be relevant to
Registry conditions: Nephrolithiasis, Urolithiasis, Endourology. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison Study Between Using Retrograde Flexible Ureteroscopy With Flexible & Navigable Suction Ureteral Access Sheath Versus Retrograde Flexible Ureteroscopy With Antegrade Suction in Lower Calyceal Stone: A Randomized Controlled Trial

Overview

This randomized controlled trial aims to compare the efficacy and safety of two suction techniques during retrograde flexible ureteroscopy (FURS) for lower calyceal renal stones measuring 1.5-2 cm. The study evaluates Flexible \& Navigable Suction Ureteral Access Sheath (FANS) versus Antegrade Suction (via percutaneous access) in improving stone-free rates (SFR), reducing operative time, and minimizing complications such as bleeding, ureteral injury, and infection. A total of 120 adult patients will be randomized into two groups, undergoing either flexible ureteroscopy (FURS) with Flexible \& Navigable Suction Ureteral Access Sheath (FANS) or flexible ureteroscopy (FURS) with antegrade suction, at Banha University Faculty of Medicine.

Interventions

  • Procedure Flexible & Navigable Suction Ureteral Access Sheath (FANS)
    The Flexible \& Navigable Suction Ureteral Access Sheath (FANS) is used during retrograde flexible ureteroscopy (FURS) for renal stones (1.5-2 cm). It allows continuous active suctioning, improving stone fragment evacuation, reducing operative time, lowering intrarenal pressure, and optimizing stone-free rates (SFR). The procedure involves inserting the Navigator 10F, 55 cm YIGAOMED FANS over a guidewire, followed by flexible ureteroscopy with PUSEN® 9.2 Fr ureteroscope and laser lithotripsy usi
  • Procedure Antegrade Suction via Percutaneous Nephrostomy
    This technique involves antegrade suction from the kidney during flexible ureteroscopy (FURS) without the use of a ureteral access sheath. A percutaneous nephrostomy (PCN) tract is created using an 18G needle, and a 6F renal dilator is placed and fixed to the skin, allowing for direct suctioning from the collecting system. Following this, retrograde flexible ureteroscopy (FURS) is performed using the PUSEN® 9.2 Fr ureteroscope and Holmium Laser (JenaSurgical® MultiPulse HoPLUS™ 150W) for stone f

Primary outcome measures

  • Stone-Free Rate (SFR) [Time frame: 1 Month Postoperative]
Secondary outcome measures (5)
  • Operative Time [Time frame: During Surgery]
  • Intraoperative Bleeding Requiring Intervention [Time frame: During Surgery]
  • Ureteral Injury [Time frame: During Surgery]
  • Postoperative Hematuria [Time frame: Within 7 Days Postoperative]
  • Postoperative Urosepsis [Time frame: Within 7 Days Postoperative]

Eligibility criteria

Inclusion criteria

  • Adult patients (≥18 years old)
  • Patients diagnosed with renal stones (1.5-2 cm) confirmed by non-contrast computed tomography (NCCT)
  • Patients undergoing flexible ureteroscopy (FURS) as the primary treatment approach
  • Patients with no active urinary tract infection (UTI) at baseline
  • Patients who provide written informed consent

Exclusion criteria

  • Patients with anatomical anomalies (e.g., horseshoe kidney, PUJ obstruction)
  • Patients with a single functioning kidney
  • Pregnant women
  • Patients with a history of urological malignancy
  • Patients with active bleeding disorders or those on anticoagulant therapy that cannot be safely discontinued
  • Patients at high risk for anesthesia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06889051 · MD-290-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗