[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657717":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":34,"overallOfficials":44,"centralContacts":48,"locations":13,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":13,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":13,"enrollmentInfo":72,"targetDuration":13,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":87,"whyStopped":13,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":13},{"fullName":5,"class":6},"University of Kansas Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Approximately 3 months postoperatively",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","This is a prospective, single-center, single-blinded, randomized controlled trial evaluating two predefined irrigation and suction pressure configurations using the ClearPetra™ 11\u002F13 Fr Flexible and Navigable Suction Access Sheath (FANS) during retrograde intrarenal surgery (RIRS).\n\nApproximately 100 adult patients undergoing flexible ureteroscopy for treatment of kidney stones with a total stone burden of 1.0 to 2.5 cm will be enrolled. Participants will be randomized in a 1:1 ratio to one of two treatment groups. The high-flow group will undergo RIRS using irrigation at 250 mmHg with an automated irrigation pump and suction at 200 mmHg. The moderate-flow group will undergo RIRS using irrigation at 150 mmHg and suction at 120 mmHg.\n\nThe primary objective is to evaluate the effect of these irrigation and suction settings on procedural and postoperative outcomes. The primary outcome is stone-free status assessed by postoperative computed tomography approximately three months after surgery. Stone-free status is defined in the protocol as no residual stone fragments greater than 2 mm.\n\nSecondary outcomes include basket use, total operative time, laser time, total laser energy, and postoperative infection within 30 days. Additional exploratory assessments will evaluate the ability of the FANS sheath to reach the upper and lower pole calyces, sheath length selection, intraoperative deflection characteristics, and the amount of sheath remaining outside the patient during upper-pole access.\n\nParticipants will undergo clinical care and follow-up according to standard practice. Follow-up information will be collected approximately three months after surgery, and long-term follow-up will continue for up to 12 months to assess subsequent stone events, additional treatments or reinterventions, and available stone-related imaging.",[22,28],{"label":23,"type":24,"description":25,"interventionNames":26},"High-Flow FANS Setting","EXPERIMENTAL","Participants will undergo retrograde intrarenal surgery (RIRS) using the ClearPetra™ vacuum-assisted ureteral access sheath with irrigation pressure of 250 mmHg using an automated irrigation pump and suction pressure of 200 mmHg.",[27],"Device: ClearPetra™ FANS - High-Flow Setting",{"label":29,"type":30,"description":31,"interventionNames":32},"Moderate-Flow FANS Setting","ACTIVE_COMPARATOR","Participants will undergo retrograde intrarenal surgery (RIRS) using the ClearPetra™ vacuum-assisted ureteral access sheath with irrigation pressure of 150 mmHg using an automated irrigation pump and suction pressure of 120 mmHg.",[33],"Device: ClearPetra™ FANS - Moderate-Flow Setting",[35,40],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":13},"DEVICE","ClearPetra™ FANS - High-Flow Setting","ClearPetra™ 11\u002F13 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.",[23],{"type":36,"name":41,"description":42,"armGroupLabels":43,"otherNames":13},"ClearPetra™ FANS - Moderate-Flow Setting","ClearPetra™ 11\u002F13 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.",[29],[45],{"name":46,"affiliation":5,"role":47},"Wilson Molina, md","PRINCIPAL_INVESTIGATOR",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":13,"email":53},"Wilson Molina, Md","CONTACT","913-588-6146","wmolina@kumc.edu",{"name":55,"role":51,"phone":13,"phoneExt":13,"email":56},"Bristol B. Whiles, md","bwhiles@kumc.edu",{"type":58,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR",[60],{"name":61,"class":62},"KARL STORZ Endoscopy-America, Inc.","INDUSTRY","100657717","fans-optimization-of-irrigation-and-suction-parameters-in-rirs-a-rct-100657717",false,"NCT07840482","FANS-Optimization of Irrigation and Suction Parameters in RIRS","ClearPetra™ Vacuum-Assisted Ureteral Access Sheath Optimization of Irrigation and Suction Parameters in FANS-Assisted Flexible Ureteroscopy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Male or female participants aged 18 years or older.\n* Undergoing flexible ureteroscopy for retrograde intrarenal surgery.\n* Total stone burden between 1.0 and 2.5 cm.\n\nExclusion Criteria:\n\n* Undergoing bilateral stone treatment during the same procedure.\n* Known genitourinary anatomical abnormalities.\n* Uncorrected coagulopathy.\n* Urinary diversion.\n* Chronic external urinary catheter.\n* Pregnancy.\n* Immunosuppression.\n* Participation in another clinical research study during the duration of this trial, unless the investigator determines on a case-by-case basis that participation in the other study will not adversely affect the outcomes or integrity of this trial.","ALL","18 Years",{"count":73,"type":74},100,"ESTIMATED","INTERVENTIONAL",[77],"NA","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.\n\nThe 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.",[80],"Stone, Kidney",[82,83,84,85,86],"Stone","FANS","Suction sheath","ureteroscopy","irrigation settings","NOT_YET_RECRUITING","2026-09-25",{"date":90,"type":91},"2026-09-30","ACTUAL",{"date":93,"type":74},"2026-11-01",{"date":95,"type":74},"2029-11-01",{"name":5,"class":6}]