[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tingting Xu\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":4,"eligibilityCriteria":13,"healthyVolunteers":14,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":25,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100612245",false,"NCT07251075","Clinical Performance of a Point-of-Care Creatinine Testing System in Individuals With Kidney Disease","Inclusion Criteria:\n\n* Abnormal creatinine levels or suspected kidney disease;\n* Aged 18 and above, gender is not limited;\n* Voluntarily participate in this clinical study by signing the informed consent form.\n\nExclusion Criteria:\n\n* The HCT range is not within 25-65%;\n* Severe mental illness or other conditions that make the patient unable to cooperate;\n* Inability to read or write in English language;\n* Incomplete subject information (including but not limited to gender, age, education level, clinical diagnosis information; etc.);\n* Previous experience with this creatinine monitoring system or similar self-monitoring devices (including but not limited to those for glucose, ketones, total cholesterol, etc.);\n* Other conditions that, in the opinion of the investigator, make participation in this clinical trial inappropriate.",true,"ALL","18 Years",{"count":18,"type":19},200,"ESTIMATED","OBSERVATIONAL","The goal of this clinical performance study is to evaluate the accuracy and usability of the Eaglenos Creatinine Test System（referred to as EG）, a point-of-care testing (POCT) system that consists of a handheld device and its associated creatinine test strips, intended for home use by laypersons with non-dialysis-dependent kidney disease.\n\nThe main questions it aims to answer are:\n\n1. How consistent are creatinine measurements from the investigational creatinine test system compared with the clinical standard method?\n2. How usable is the Creatinine Monitoring System for laypersons in a home setting?\n\nResearchers will compare creatinine results obtained with the investigational creatinine test system (fingerstick capillary whole blood) to those from a Cobas biochemical analysis system（referred to as Cobas) (venous plasma) to determine whether the investigational device provides accurate and reliable measurements.\n\nParticipants will:\n\n1. Provide a venous blood sample for comparative testing.\n2. Perform self-testing using the Creatinine Monitoring System without prior training.\n3. Complete a usability questionnaire about their experience with the investigational creatinine test system.",[23,24],"Chronic Kidney Diseases","Kidney Injury, Acute",[26,27,28,29,30],"Creatinine","Chronic kidney diseases","Kidney Injury, acute","POCT","Eaglenos","NOT_YET_RECRUITING","2025-11-18",{"date":34,"type":35},"2025-11-26","ACTUAL",{"date":37,"type":19},"2025-11-30",{"date":39,"type":19},"2025-12-30",{"name":41,"class":42},"Tingting Xu","INDUSTRY",""]