Clinical Trial

Flexible and Navigable Suction Ureteral Access Sheath (FANS) vs Conventional Access Sheaths in RIRS: A Prospective Randomized Study.

Completed
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Summary
Kidney stones located in the kidney are commonly treated using a minimally invasive procedure called retrograde intrarenal surgery (RIRS). During this procedure, a ureteral access sheath is often used to facilitate repeated access to the kidney, improve visualization, and allow irrigation fluid to drain. Newer access sheaths have been developed with flexible distal tips and built-in suction capabilities, which may help reduce operative time by improving visibility and removing stone fragments and irrigation fluid more efficiently. This prospective randomized study compared a flexible and navigable suction ureteral access sheath with a conventional ureteral access sheath in adult patients undergoing RIRS for kidney stones measuring 10 mm or larger. Participants were randomly assigned to one of the two access sheath types. The primary objective of the study was to evaluate whether the use of a suction-enabled access sheath reduces operative time. Secondary objectives included assessment of complications, length of hospital stay, stone-free rate, and need for additional interventions.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-01-26; most recent amendment 2026-06-24.
Trial Details
NCT Number NCT07377461
Lead Sponsor Barzilai Medical Center
Conditions Kidney Stones, Nephrolithiasis
Enrollment 50 participants
Start Date 2025-01-01
Primary Completion 2025-11-01 (estimated)
Study Completion 2025-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-25