New suction sheath aims to clean up kidney stone surgery

NCT ID NCT07463157

Not yet recruiting Symptom relief Sponsor: IRCCS San Raffaele Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a new ureteral access sheath with built-in suction (FANS) to the standard sheath used during kidney stone removal surgery. The goal is to see if the suction device helps clear more stone fragments and reduces infections. About 134 adults with kidney stones will be randomly assigned to receive surgery with either the new or standard sheath.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Flexible and Navigable Suction (FANS) ureteral access sheath (Elephant-II)
What this could lead to: If it works, this could make kidney stone surgery more effective at removing all fragments and lower the risk of post-surgery infections.
What could go wrong: This is a small, early-stage trial at one center. The new device may not significantly improve outcomes over the standard sheath, and there could be unforeseen complications.

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Conditions

The condition(s) this trial relates to.

Kidney Calculi nephrolithiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

RENAL CALCULI

Contacts and locations

Locations

IRCCS Ospedale San Raffaele

Milan, Italy

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