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NCT Number: NCT07559214

FANS VS DISS in Treatment of Renal Stone < 2cm

To compare between FANS & DISS in :

* Operative time * Stone free rate * Complications * Amount of fluid irrigation

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Key information

About this study

Retrograde intrarenal surgery (RIRS) has revolutionized the management of renal stones, yet achieving high stone-free rates (SFR) while maintaining low intrarenal pressure (IRP) remains a challenge. Elevated IRP during irrigation is linked to post-operative complications, including systemic inflammatory response syndrome and renal parenchymal damage. To mitigate these risks, suction-assisted technologies have emerged as vital adjuncts to traditional flexible ureteroscopy (FURS).The Flexible and Navigable Access Sheath (FANS) represents a significant evolution in this field. Unlike traditional rigid sheaths, FANS features a deflectable tip that can be guided into specific calyces, allowing for synchronized suction and active fragment evacuation. Conversely, Direct In-Scope Suction (DISS) utilizes a sheathless approach, where suction is integrated directly into the ureteroscope. While DISS avoids potential ureteral trauma associated with access sheaths, FANS is often associated with shorter operative times due to its superior irrigation-aspiration efficiency.For renal stones measuring less than 2 cm, both techniques aim to optimize the "perfusion-absorption" balance, effectively clearing stone dust and debris while preventing pyelovenous reflux. However, comparative data specifically for smaller stones remains limited. This study evaluates the clinical efficacy, safety profiles, and operative outcomes of FANS versus DISS in the treatment of renal calculi < 2 cm, aiming to determine which suction modality provides the most favorable balance of procedural efficiency and patient safety.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients < 18 years old presented with renal stone > 2cm whatever the site of the stone (pelvic or calyceal)

Exclusion criteria

  • Inaccessibility to introduce access sheath or FURS
  • Previous Inserted JJ stent
  • Active UTI
  • Patients refuse to participate in the protocol

Treatment and study plan

flexible ureteroscopy

Procedure

Unlike traditional rigid sheaths, FANS features a deflectable tip that can be guided into specific calyces, allowing for synchronized suction and active fragment evacuation. Conversely, Direct In-Scope Suction (DISS) utilizes a sheathless approach, where suction is integrated directly into the ureteroscope. While DISS avoids potential ureteral trauma associated with access sheaths, FANS is often associated with shorter operative times due to its superior irrigation-aspiration efficiency

Other names: FURS

Primary outcomes

  1. Operative time

    Time frame: <60 minutes

    The operative time is the duration of surgical procedure

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Flexible and Navigable Access Sheath (FANS) VS Direct in Scope Suction (DISS) in Treatment of Renal Stone > 2 cm , Controlled Randomized Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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