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FANS VS DISS in Treatment of Renal Stone < 2cm

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07559214
Enrollment
100
Registered
2026-04-30
Start date
2026-06-01
Completion date
2027-09-01
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Calculi

Brief summary

To compare between FANS & DISS in : * Operative time * Stone free rate * Complications * Amount of fluid irrigation

Detailed description

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.

Interventions

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Operative time<60 minutesThe operative time is the duration of surgical procedure

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026