FANS-Optimization of Irrigation and Suction Parameters in RIRS
ConditionStone, Kidney
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participants aged 18 years or older.
Undergoing flexible ureteroscopy for retrograde intrarenal surgery.
Total stone burden between 1.0 and 2.5 cm.
Disqualifiers
Undergoing bilateral stone treatment during the same procedure.
Known genitourinary anatomical abnormalities.
Uncorrected coagulopathy.
Urinary diversion.
Trial design
Design model
Parallel
Treatments tested in this trial
ClearPetra™ FANS - High-Flow Setting
DeviceClearPetra™ 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.
ClearPetra™ FANS - Moderate-Flow Setting
DeviceClearPetra™ 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: High-Flow FANS SettingExperimental treatment 1 intervention
Group B: Moderate-Flow FANS SettingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Stone-Free Rate (SFR)
Stone-free status will be assessed using postoperative imaging. Stone free is defined as no residual stone fragments greater than 2 mm visible on imaging. The proportion of participants meeting this definition will be compared between the two study arms.
Time frame
Approximately 3 months postoperativelyLocations
Sponsors and contacts
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University of Kansas Medical Center
Lead sponsor
KARL STORZ Endoscopy-America, Inc.
Collaborator
Source ClinicalTrials.gov
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