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COMPLETED
NCT07377461
NA

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

Sponsor: Barzilai Medical Center

View on ClinicalTrials.gov

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.

Official title: Comparative Study of Access Sheaths With Flexible Tips and Suction Versus Conventional Access in Endourology: A Prospective Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-01-01

Completion Date

2025-11-30

Last Updated

2026-06-25

Healthy Volunteers

No

Interventions

DEVICE

Flexible and Navigable Suction Ureteral Access Sheath (FANS)

Use of a flexible distal-tip ureteral access sheath with integrated suction during retrograde intrarenal surgery to facilitate access, irrigation control, and fragment evacuation.

DEVICE

Conventional Ureteral Access Sheath

Use of a standard ureteral access sheath without suction during retrograde intrarenal surgery.

Locations (1)

Barzilai University Medical Center

Ashkelon, Israel