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FANS-Optimization of Irrigation and Suction Parameters in RIRS

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 9 words Study title shortened, about 2 words Show 1 more changeShow less
    • Study title shortened, about 2 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07840482
Lead Sponsor University of Kansas Medical Center
Collaborators: KARL STORZ Endoscopy-America, Inc.
Conditions Stone, Kidney
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov