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NOT YET RECRUITING
NCT07840482
NA

FANS-Optimization of Irrigation and Suction Parameters in RIRS

Sponsor: University of Kansas Medical Center

View on ClinicalTrials.gov

Summary

Kidney stones are commonly treated with flexible ureteroscopy, a minimally invasive procedure in which a small scope is passed through the urinary tract to reach and treat stones in the kidney. Flexible and navigable suction access sheaths (FANS), such as the ClearPetra™ system, allow irrigation and suction to be used during the procedure to help remove stone fragments. The purpose of this randomized study is to compare two different irrigation and suction pressure settings used with the ClearPetra™ FANS system during flexible ureteroscopy. Approximately 100 adults undergoing ureteroscopy for kidney stones will be randomly assigned to either a higher-flow setting or a moderate-flow setting. The study will compare stone clearance, operative characteristics, and postoperative outcomes to determine which setting provides the most effective and safe treatment conditions.

Official title: ClearPetra™ Vacuum-Assisted Ureteral Access Sheath Optimization of Irrigation and Suction Parameters in FANS-Assisted Flexible Ureteroscopy: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-11-01

Completion Date

2029-11-01

Last Updated

2026-09-30

Healthy Volunteers

No

Conditions

Interventions

DEVICE

ClearPetra™ FANS - High-Flow Setting

ClearPetra™ 11/13 Fr Flexible and Navigable Suction Access Sheath (FANS) used during retrograde intrarenal surgery with irrigation pressure of 250 mmHg using an automated irrigation pump and suction pressure of 200 mmHg.

DEVICE

ClearPetra™ FANS - Moderate-Flow Setting

ClearPetra™ 11/13 Fr Flexible and Navigable Suction Access Sheath (FANS) used during retrograde intrarenal surgery with irrigation pressure of 150 mmHg using an automated irrigation pump and suction pressure of 120 mmHg.