[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658484":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":11,"studyPopulation":11,"armGroups":34,"interventions":42,"overallOfficials":11,"centralContacts":52,"locations":11,"responsibleParty":62,"collaborators":11,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":11,"enrollmentInfo":75,"targetDuration":11,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":11,"overallStatus":83,"whyStopped":11,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":89,"leadSponsor":91,"locationsCount":11},{"fullName":5,"class":6},"Botkin Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients requiring at least one episode of controlled intraoperative apnea during laser lithotripsy.",null,"intraoperative",[14,16,18,20,22,24,26],{"measure":15,"description":11,"timeFrame":12},"• number of apnea episodes;",{"measure":17,"description":11,"timeFrame":12},"total apnea duration;",{"measure":19,"description":11,"timeFrame":12},"mean number of apnea episodes per patient;",{"measure":21,"description":11,"timeFrame":12},"maximum duration of a single apnea episode;",{"measure":23,"description":11,"timeFrame":12},"minimum SpO2;",{"measure":25,"description":11,"timeFrame":12},"incidence of desaturation;",{"measure":27,"description":11,"timeFrame":12},"visible laser-induced mucosal",{"allocation":29,"interventionModel":30,"interventionModelDescription":11,"primaryPurpose":31,"observationalModel":11,"timePerspective":11,"maskingInfo":32},"RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":33,"maskingDescription":11,"whoMasked":11},"NONE",[35],{"label":36,"type":37,"description":38,"interventionNames":39},"patients with a single renal stone who are scheduled for elective retrograde intrarenal surger","EXPERIMENTAL","RIRS will be performed using a thulium fiber laser with Tissue Sensor activated. All automatic system trigger events will be recorded and, whenever possible, synchronized with the procedure video recording.",[40,41],"Procedure: RIRS without Tissue Sensor","Procedure: RIRS with Tissue Sensor",[43,48],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":11},"PROCEDURE","RIRS without Tissue Sensor","RIRS will be performed using the same TFL system with Tissue Sensor deactivated. Visually confirmed contacts between the activated laser fiber and the mucosa will be recorded from the procedure video.",[36],{"type":44,"name":49,"description":50,"armGroupLabels":51,"otherNames":11},"RIRS with Tissue Sensor","RIRS will be performed using a thulium fiber laser with Tissue Sensor activated. All automatic system trigger events will be recorded and, whenever possible, synchronized with the procedure video recording.\n\n* total number of Tissue Sensor trigger events;\n* Tissue Sensor trigger events per minute of laser activation.",[36],[53,58],{"name":54,"role":55,"phone":56,"phoneExt":11,"email":57},"Nikita Astakhov","CONTACT","+8 (968) 490-46-72","astakhov.nikita@inbox.ru",{"name":59,"role":55,"phone":60,"phoneExt":11,"email":61},"Vigen Malkhasyan, Doctor of Medical Sciences","+79096441688","botkinhospital@zdrav.mos.ru",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Malkhasyan Vigen Andreevich","Doctor of Medical science","100658484","tissue-sensor-to-reduce-the-need-for-controlled-apnea-during-retrograde-intrarenal-surgery-100658484",false,"NCT07851116","Tissue Sensor to Reduce the Need for Controlled Apnea During Retrograde Intrarenal Surgery","Tissue Sensor","Inclusion Criteria:\n\n* Age 18 years or older.\n* A single renal stone.\n* An indication for elective RIRS.\n* Feasibility of performing the intervention with a flexible ureteroscope.\n* Recommended stone diameter on CT: 7-15 mm.\n* Stone located in a calyx, a group of calyces, or the renal pelvis.\n* Feasibility of TFL use.\n* General anesthesia with controlled mechanical ventilation.\n* No active urinary tract infection.\n* Ability to undergo low-dose non-contrast CT at 1 month.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Multiple stones in the study kidney.\n* Complete or partial staghorn stone.\n* Ipsilateral ureteral stone.\n* Renal or upper urinary tract anomaly that substantially alters the anatomy.\n* Horseshoe, pelvic, or ectopic kidney.\n* Stone within a calyceal diverticulum.\n* Ureteral stricture.\n* Previous reconstructive surgery involving the study kidney or ureter.\n* Active infection, obstructive pyelonephritis, or urosepsis.\n* Nephrostomy drainage.\n* Pregnancy.\n* Severe respiratory failure or a contraindication to apnea.\n* Severe cardiovascular instability.\n* Inability to undergo general anesthesia.\n* Combined, bilateral, or percutaneous intervention.\n* Suspected upper urinary tract tumor.\n* Inability to comply with the study protocol.","ALL","18 Years",{"count":76,"type":77},130,"ESTIMATED","INTERVENTIONAL",[80],"NA","Retrograde intrarenal surgery is an established minimally invasive treatment for renal stones. During laser lithotripsy, respiratory motion causes the kidney, renal collecting system, and stone to move relative to the distal tip of the laser fiber. This can impair precise fiber positioning, reduce operative-field stability, and increase the risk of unintended laser exposure of the urothelium of the renal collecting system.\n\nTo reduce respiratory motion of the kidney, the surgeon may ask the anesthesiologist to temporarily pause mechanical ventilation. Controlled apnea can briefly stabilize the operative field; however, it requires interruption of ventilation and may cause oxygen desaturation, carbon dioxide accumulation, hemodynamic changes, and increased anesthetic burden.\n\nTissue Sensor is a technology that automatically terminates laser emission when contact between the distal tip of the laser fiber and tissue is detected. Tissue Sensor is expected to reduce the risk of unintended laser exposure of the renal collecting-system mucosa during respiratory motion of the kidney.\n\nGreater surgeon confidence in the safety of laser activation may reduce the need to stabilize the kidney with controlled apnea. At the same time, brief automatic interruptions of laser emission may increase lithotripsy time and total operative time.",[71],"NOT_YET_RECRUITING","2026-09-30",{"date":86,"type":87},"2026-10-01","ACTUAL",{"date":86,"type":77},{"date":90,"type":77},"2028-11-02",{"name":5,"class":6}]