[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612245":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":29,"collaborators":10,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":37,"acronym":10,"eligibilityCriteria":38,"healthyVolunteers":39,"sex":40,"minAge":41,"maxAge":10,"enrollmentInfo":42,"targetDuration":10,"studyType":45,"phases":10,"briefSummary":46,"conditions":47,"keywords":50,"overallStatus":56,"whyStopped":10,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":10},{"fullName":5,"class":6},"Eaglenos Sciences, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Cobas Group",null,"Blood creatinine measurements are performed using the Cobas biochemical analyzer with venous plasma. The results will be compared with those obtained from the investigational Eaglenos Creatinine Test System using fingerstick capillary whole blood.",[13],"Diagnostic Test: Reference Creatinine Test System（Cobas c 111）",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2: EG Group","Blood creatinine measurements are performed using the Eaglenos Creatinine Test System with fingerstick capillary whole blood. The results will be compared with those obtained from the Cobas biochemical analyzer using venous plasma.",[18],"Diagnostic Test: Investigational Creatinine Test System （EG）",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DIAGNOSTIC_TEST","Reference Creatinine Test System（Cobas c 111）","This group involves the use of the Cobas biochemical analyzer for measurement of venous plasma creatinine samples. The results obtained from Cobas will be compared with those obtained from the investigational Eaglenos Creatinine Test System to evaluate the accuracy and reliability of the investigational device. Study participant management and clinical care will not be influenced by the results of these study measurements.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Investigational Creatinine Test System （EG）","This group involves the use of the Eaglenos Creatinine Test System, a handheld device designed for self-testing of fingerstick capillary whole blood by laypersons with non-dialysis-dependent kidney disease. The results obtained from EG will be compared with those obtained from the Cobas biochemical analyzer to evaluate the accuracy and reliability of the investigational device. Study participant management and clinical care will not be influenced by the results of these study measurements.",[15],{"type":30,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Tingting Xu","Regulatory Affair Supervisor","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":43,"type":44},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.",[48,49],"Chronic Kidney Diseases","Kidney Injury, Acute",[51,52,53,54,55],"Creatinine","Chronic kidney diseases","Kidney Injury, acute","POCT","Eaglenos","NOT_YET_RECRUITING","2025-11-18",{"date":59,"type":60},"2025-11-26","ACTUAL",{"date":62,"type":44},"2025-11-30",{"date":64,"type":44},"2025-12-30",{"name":31,"class":6}]