[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657180":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":25,"interventions":37,"overallOfficials":18,"centralContacts":46,"locations":18,"responsibleParty":56,"collaborators":18,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":18,"enrollmentInfo":70,"targetDuration":18,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":18,"overallStatus":79,"whyStopped":18,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":18},{"fullName":5,"class":6},"Botkin Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of intraoperative laser-induced injury to the ureteral mucosa","Incidence of intraoperative laser-induced injury to the ureteral mucosa, defined as any visible injury compatible with exposure to an activated laser fiber, as determined by independent blinded video assessment.","intraoperative",[14],{"measure":15,"description":16,"timeFrame":17},"Incidence of postoperative ureteral stricture","Incidence of postoperative ureteral stricture detected during the 12 months after the intervention.\n\n* Stone-free rate on low-dose non-contrast CT at 1 month.\n* Incidence and total number of Tissue Sensor trigger events in the TS group.\n* Incidence and total number of visually confirmed contacts between an activated laser fiber and the mucosa in the control group.\n* Number of trigger events or contacts per minute of laser activation.\n* Severity of mucosal injury according to the standardized scale.\n* Total operative time.\n* Lithotripsy time.\n* Cumulative laser activation time.\n* Migration of the stone or fragments into the kidney.\n* Need for conversion to flexible ureteroscopy or repeat intervention.\n* Type and duration of postoperative drainage.\n* Postoperative complications according to the Clavien-Dindo classification.\n* New or progressive hydronephrosis during follow-up.","12 months.",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE",[26,32],{"label":27,"type":28,"description":29,"interventionNames":30},"Patients after ureterolithotrypsy with Tissue Sensor activated","EXPERIMENTAL","Semirigid TFL ureterolithotripsy will be performed with Tissue Sensor activated. All automatic system trigger events will be recorded by the laser system or in the study case report form and, whenever possible, synchronized with the procedure video recording",[31],"Procedure: Semirigid TFL ureterolithotripsy with Tissue Sensor activated.",{"label":33,"type":28,"description":34,"interventionNames":35},"Patients after ureterolithotrypsy with Tissue Sensor deactivated","Semirigid TFL ureterolithotripsy will be performed with Tissue Sensor deactivated. Visually confirmed contacts between the activated laser fiber and the ureteral mucosa will be recorded from the procedure video",[36],"Procedure: Semirigid TFL ureterolithotripsy with Tissue Sensor deactivated.",[38,42],{"type":39,"name":40,"description":29,"armGroupLabels":41,"otherNames":18},"PROCEDURE","Semirigid TFL ureterolithotripsy with Tissue Sensor activated.",[27],{"type":39,"name":43,"description":44,"armGroupLabels":45,"otherNames":18},"Semirigid TFL ureterolithotripsy with Tissue Sensor deactivated.","Semirigid TFL ureterolithotripsy will be performed with Tissue Sensor deactivated. Visually confirmed contacts between the activated laser fiber and the ureteral mucosa will be recorded from the procedure video.",[33],[47,52],{"name":48,"role":49,"phone":50,"phoneExt":18,"email":51},"Nikita Astakhov","CONTACT","+8 (968) 490-46-72","astakhov.nikita@inbox.ru",{"name":53,"role":49,"phone":54,"phoneExt":18,"email":55},"Vigen Malkhasyan, Doctor of Medical Sciences","+79096441688","botkinhospital@zdrav.mos.ru",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Malkhasyan Vigen Andreevich","Doctor of medical science","100657180","tissue-sensor-for-semirigid-thulium-fiber-laser-ureterolithotripsy-100657180",false,"NCT07835113","Tissue Sensor for Semirigid Thulium Fiber Laser Ureterolithotripsy","Tissue Sensor to Reduce Laser-Induced Ureteral Injury During Semirigid Thulium Fiber Laser Ureterolithotripsy: The TISSUE Multicenter Randomized Controlled Trial","Tissue Sensor","Inclusion Criteria:\n\n* • Age 18 years or older.\n\n  * A single stone in the mid or distal ureter.\n  * Maximum stone diameter of 15 mm or less on preoperative CT.\n  * An indication for elective semirigid laser ureterolithotripsy.\n  * Feasibility of performing the procedure with a semirigid ureteroscope.\n  * No active urinary tract infection at the time of the intervention.\n  * Ability to undergo CT follow-up and complete 12 months of follow-up.\n  * Signed written informed consent.\n\nExclusion Criteria:\n\n* • Age 18 years or older.\n\n  * A single stone in the mid or distal ureter.\n  * Maximum stone diameter of 15 mm or less on preoperative CT.\n  * An indication for elective semirigid laser ureterolithotripsy.\n  * Feasibility of performing the procedure with a semirigid ureteroscope.\n  * No active urinary tract infection at the time of the intervention.\n  * Ability to undergo CT follow-up and complete 12 months of follow-up.\n  * Signed written informed consent.","ALL","18 Years",{"count":71,"type":72},121,"ESTIMATED","INTERVENTIONAL",[75],"NA","Tissue Sensor (TS) is a technology designed to automatically deactivate laser emission when contact between the laser fiber and tissue is detected. It is hypothesized that the use of TS during contact laser ureterolithotripsy may reduce unintended laser exposure of the ureteral mucosa, thereby decreasing the risk of immediate thermal injury to the ureteral wall and subsequent scar-related narrowing.\n\nTo reduce the influence of baseline risk factors for stricture, the study will enroll a homogeneous population of patients without urinary tract anomalies, previous surgery on the study ureter, or impacted stones. The procedure will be performed according to a standardized protocol using a semirigid ureteroscope, a thulium fiber laser, and predefined technical restrictions. The study is limited to patients with stones in the mid or distal ureter. This approach is intended to minimize the likelihood of stone retropulsion into the kidney, standardize the surgical technique, reduce the need for conversion to flexible ureteroscopy, and maximize comparability between the study groups.",[78],"Nephrolithiasis","NOT_YET_RECRUITING","2026-09-17",{"date":82,"type":83},"2026-09-22","ACTUAL",{"date":85,"type":72},"2026-10-01",{"date":87,"type":72},"2028-11-02",{"name":5,"class":6}]