[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654281":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":67,"studyPopulation":55,"armGroups":68,"interventions":81,"overallOfficials":89,"centralContacts":94,"locations":103,"responsibleParty":127,"collaborators":55,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":131,"sex":137,"minAge":138,"maxAge":55,"enrollmentInfo":139,"targetDuration":55,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":150,"overallStatus":165,"whyStopped":55,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},{"fullName":5,"class":6},"Sault Area Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":55},[9,13],{"measure":10,"description":11,"timeFrame":12},"Stone Free Rate","Stone-free status defined as the absence of residual stone fragments greater than 2 mm on non-contrast CT KUB","1 month after surgery",{"measure":14,"description":15,"timeFrame":16},"Primary Renal Access Success Rate","Successful passage of the flexible ureteroscope into the renal collecting system without the need for preoperative ureteral stenting","Perioperative\u002FPeriprocedural",[18,22,25,28,32,36,40,44,47,51],{"measure":19,"description":20,"timeFrame":21},"Operative Time","Total operative time measured from insertion of the ureteroscope until completion of the procedure","During surgery",{"measure":23,"description":24,"timeFrame":21},"Intraoperative Fluoroscopy Use","Fluoroscopy utilization during the procedure, including fluoroscopy time",{"measure":26,"description":27,"timeFrame":16},"Intraoperative Ureteral Trauma as Assessed by the Traxer Ureteral Injury Scale","Ureteral trauma will be assessed using the Traxer Ureteral Injury Scale, graded from 0 to 3, where Grade 0 indicates no observable ureteral injury and Grade 3 indicates the most severe ureteral injury. Higher scores indicate greater severity of ureteral injury.",{"measure":29,"description":30,"timeFrame":31},"Postoperative Ureteral Stenting Rate","Percentage of participants requiring ureteral stent placement at the end of surgery","Immediately after surgery",{"measure":33,"description":34,"timeFrame":35},"Postoperative Pain as Assessed by the Visual Analog Scale","Postoperative pain will be assessed using the Visual Analog Scale, ranging from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. Higher scores indicate greater pain.","6, 24, and 48 hours after surgery",{"measure":37,"description":38,"timeFrame":39},"Postoperative Complications","Complications graded using the Clavien-Dindo Classification","Up to 30 days after surgery",{"measure":41,"description":42,"timeFrame":43},"Emergency Department Visits","Emergency department visits related to the procedure","Within 2 weeks after surgery",{"measure":45,"description":46,"timeFrame":16},"Hospital Length of Stay","Length of hospital stay measured in hours from admission for the index ureteroscopy procedure to hospital discharge.",{"measure":48,"description":49,"timeFrame":50},"Need for Secondary Procedures","Requirement for additional stone-related procedures","Up to 1 month after surgery",{"measure":52,"description":53,"timeFrame":54},"Incremental Cost-Effectiveness Ratio Comparing 6.3Fr and 7.5Fr Mini-Flexible Ureteroscopes","The incremental cost-effectiveness ratio (ICER) will compare the additional direct medical cost associated with the 6.3Fr versus 7.5Fr mini-flexible ureteroscope relative to the incremental clinical effectiveness. Direct medical costs will include ureteroscope acquisition costs, repair costs, procedure-related disposables, operating room time, hospital stay, management of complications, readmissions, and secondary procedures. Clinical effectiveness will be assessed primarily using stone-free and successful primary access outcomes.","From surgery through 30 days after surgery",null,{"allocation":57,"interventionModel":58,"interventionModelDescription":59,"primaryPurpose":60,"observationalModel":55,"timePerspective":55,"maskingInfo":61},"RANDOMIZED","PARALLEL","Participants will be randomized in a 1:1 ratio to undergo flexible ureteroscopy using either a 6.3Fr or a 7.5Fr mini-flexible ureteroscope. Outcomes will be compared between the two parallel groups","TREATMENT",{"masking":62,"maskingDescription":63,"whoMasked":64},"DOUBLE","Participants and outcome assessors, including staff collecting postoperative outcomes and radiologists evaluating imaging studies, will be blinded to treatment allocation. Operating surgeons and operating room personnel will not be blinded because they must know which ureteroscope is being used during the procedure",[65,66],"PARTICIPANT","OUTCOMES_ASSESSOR","Renal stone disease is a common condition with an increasing global incidence. Flexible ureteroscopy has become one of the standard treatments for renal stones because it provides excellent stone clearance with a minimally invasive approach. Recent technological advances have led to the development of mini-flexible ureteroscopes with smaller diameters, which may facilitate easier access to the kidney while reducing ureteral trauma and the need for preoperative ureteral stenting.\n\nAlthough both 6.3Fr and 7.5Fr mini-flexible ureteroscopes are currently available for clinical use, there is limited high-level evidence comparing their clinical performance and cost-effectiveness. This prospective, randomized, single-blinded, non-inferiority trial aims to compare these two ureteroscope sizes in adult patients undergoing flexible ureteroscopy for renal stones.\n\nEligible participants will be randomized in a 1:1 ratio to undergo flexible ureteroscopy using either a 6.3Fr or a 7.5Fr mini-flexible ureteroscope. All procedures will be performed using standardized surgical techniques by experienced endourologists.\n\nThe primary outcomes are stone-free rate at one month after surgery and successful primary renal access without preoperative ureteral stenting. Secondary outcomes include operative time, fluoroscopy utilization, intraoperative ureteral trauma, postoperative ureteral stenting, postoperative pain, complications classified using the Clavien-Dindo system, emergency department visits, hospital length of stay, need for secondary procedures, and cost-effectiveness from the hospital payer perspective.\n\nThe investigators hypothesize that the 6.3Fr mini-flexible ureteroscope will improve primary renal access while reducing ureteral trauma, fluoroscopy exposure, postoperative stenting, and overall healthcare costs without compromising stone-free rates. The findings of this study may help establish evidence-based recommendations for selecting mini-flexible ureteroscopes and optimize the surgical management of patients with renal stone disease.",[69,75],{"label":70,"type":71,"description":72,"interventionNames":73},"6.3Fr Mini-Flexible Ureteroscope","EXPERIMENTAL","Participants randomized to this arm will undergo flexible ureteroscopy using a 6.3Fr mini-flexible ureteroscope for the treatment of renal stones according to the study protocol",[74],"Device: 6.3Fr Mini-Flexible Ureteroscope",{"label":76,"type":77,"description":78,"interventionNames":79},"7.5Fr Mini-Flexible Ureteroscope","ACTIVE_COMPARATOR","Participants randomized to this arm will undergo flexible ureteroscopy using a 7.5Fr mini-flexible ureteroscope for the treatment of renal stones according to the study protocol",[80],"Device: 7.5Fr Mini-Flexible Ureteroscope",[82,86],{"type":83,"name":70,"description":84,"armGroupLabels":85,"otherNames":55},"DEVICE","Use of a disposable 6.3Fr mini-flexible ureteroscope during flexible ureteroscopy for renal stone treatment",[70],{"type":83,"name":76,"description":87,"armGroupLabels":88,"otherNames":55},"Use of a disposable 7.5Fr mini-flexible ureteroscope during flexible ureteroscopy for renal stone treatment",[76],[90],{"name":91,"affiliation":92,"role":93},"Yasser A Noureldin, MD, PhD","Urologist, Sault Area Hospital, Sault Ste. Marie, ON, Canada, and Assistant Professor of Urology, Northern Ontario School of Medicine University, ON, Canada","PRINCIPAL_INVESTIGATOR",[95,99],{"name":91,"role":96,"phone":97,"phoneExt":55,"email":98},"CONTACT","416-318-2239","noureldiny@sah.on.ca",{"name":100,"role":96,"phone":101,"phoneExt":55,"email":102},"Asad O Naveed, MD","6478700880","naveeda@sah.on.ca",[104],{"facility":5,"status":55,"city":105,"state":106,"zip":107,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":115,"contacts":116},"Sault Ste. Marie","Ontario","P6B 0A8","Canada","CA",{"type":111,"coordinates":112},"Point",[113,114],-84.33325,46.51677,{"lat":114,"lon":113},[117,120,124,125],{"name":118,"role":96,"phone":97,"phoneExt":55,"email":119},"Yasser A Noureldin, MD, PhD (Urol), FEBU, FACS","ynoureldin@nosm.ca",{"name":121,"role":96,"phone":122,"phoneExt":55,"email":123},"Ali O Abdelhady, MD","5042664549","aliabdelhady453@gmail.com",{"name":118,"role":93,"phone":55,"phoneExt":55,"email":55},{"name":121,"role":126,"phone":55,"phoneExt":55,"email":55},"SUB_INVESTIGATOR",{"type":128,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR","100654281","63fr-versus-75fr-mini-flexible-ureteroscopy-for-renal-stones-mini-furs-100654281",false,"NCT07798336","6.3Fr Versus 7.5Fr Mini-Flexible Ureteroscopy for Renal Stones (MINI-FURS)","Outcomes and Cost-Effectiveness of 6.3French vs. 7.5French Mini-Flexible Ureteroscopy in the Treatment of Renal Stones: A Non-Inferiority, Prospective, Randomized, Single-Blinded Study","MINI-FURS","Inclusion Criteria: \\* Adults aged 18 years or older.\n\n* Scheduled to undergo flexible ureteroscopy for renal stones.\n* Renal stone size ≤15 mm in the greatest dimension.\n* No indwelling ureteral stent at the time of surgery.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria: \\* Active urinary tract infection.\n\n* Anatomical abnormalities of the urinary tract (e.g., ureteral stricture, horseshoe kidney, ectopic kidney).\n* Solitary kidney.\n* Pregnancy.\n* Stones located within a calyceal diverticulum.\n* Any condition that, in the opinion of the investigator, would interfere with study participation or follow-up.","ALL","18 Years",{"count":140,"type":141},308,"ESTIMATED","INTERVENTIONAL",[144],"NA","This prospective, randomized, single-blinded, non-inferiority clinical trial will compare the clinical outcomes and cost-effectiveness of two mini-flexible ureteroscopes (6.3Fr and 7.5Fr) used during flexible ureteroscopy for the treatment of renal stones. Adult patients with renal stones up to 15 mm who are scheduled to undergo flexible ureteroscopy will be randomly assigned to one of the two study groups. The primary objectives are to compare stone-free rates and the ability to achieve primary renal access without preoperative ureteral stenting. Secondary outcomes include operative time, fluoroscopy use, ureteral trauma, postoperative stenting, pain, complications, emergency department visits, need for additional procedures, hospital stay, and cost-effectiveness. The results of this study are expected to provide high-quality evidence to guide the selection of mini-flexible ureteroscopes and improve the quality, safety, and value of surgical care for patients with kidney stones.",[147,148,149],"Kidney Stones","Nephrolithiasis","Renal Calculi",[151,152,153,154,155,156,148,157,158,159,160,161,162,163,164],"Flexible ureteroscopy","Mini-flexible ureteroscopy","Mini ureteroscope","Ureteroscopy","Renal stones","Kidney stones","Endourology","Laser lithotripsy","Thulium fiber laser","Randomized controlled trial","Stone free rate","Cost effectiveness","Ureteroscope 6.3Fr","Ureteroscope 7.5Fr","NOT_YET_RECRUITING","2026-09-01",{"date":168,"type":169},"2026-09-04","ACTUAL",{"date":171,"type":141},"2026-10-01",{"date":173,"type":141},"2028-08-31",{"name":5,"class":6},1]