[{"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:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100612245","clinical-performance-of-a-point-of-care-creatinine-testing-system-in-individuals-with-kidney-disease-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":19,"type":20},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.",[24,25],"Chronic Kidney Diseases","Kidney Injury, Acute",[27,28,29,30,31],"Creatinine","Chronic kidney diseases","Kidney Injury, acute","POCT","Eaglenos","NOT_YET_RECRUITING","2025-11-18",{"date":35,"type":36},"2025-11-26","ACTUAL",{"date":38,"type":20},"2025-11-30",{"date":40,"type":20},"2025-12-30",{"name":42,"class":43},"Tingting Xu","INDUSTRY",""]