[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100427458":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":19,"locations":25,"responsibleParty":38,"collaborators":19,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":19,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":49,"maxAge":19,"enrollmentInfo":50,"targetDuration":19,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":19,"overallStatus":59,"whyStopped":19,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},{"fullName":5,"class":6},"Essity Hygiene and Health AB","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Investigational Device","EXPERIMENTAL","TENA SmartCare Change Indicator",[13],"Device: TENA SmartCare Change Indicator",[15],{"type":16,"name":11,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Each participating subject will be provided with TENA SmartCare Change Indicator and incontinence products for the duration of the investigation. Each participating subject will be allocated to the incontinence type(s) that are considered most suitable.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Prof. Piotr Radziszewski, MD, PhD","Medical Concierge Centrum Medyczne, Polnej Rózy 6\u002FU2, 02-798 Warszawa,","PRINCIPAL_INVESTIGATOR",[26],{"facility":27,"status":19,"city":28,"state":19,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":19},"Medical Concierge Centrum Medyczne","Warsaw","02-798","Poland","PL",{"type":33,"coordinates":34},"Point",[35,36],21.01178,52.22977,{"lat":36,"lon":35},{"type":39,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100427458","investigation-of-the-ability-of-the-tena-smartcare-change-indicator-to-reduce-the-number-of-manual-checks-between-changes-of-absorbing-incontinence-products-100427458",true,"NCT04846270","Investigation of the Ability of the TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products","An Open, Single-arm, Post-market Clinical Investigation to Verify the Ability of TENA SmartCare Change Indicator to Reduce the Number of Manual Checks Between Changes of Absorbing Incontinence Products in a Home Environment.","Inclusion Criteria:\n\n1. DEU is diagnosed with urinary incontinence managed with a tape-style incontinence product.\n2. DEU is unable to sufficiently communicate the need for an incontinence product to be changed.\n3. DEU is being cared for in a home environment and most of the care is provided by a main CGR.\n4. DEU is willing and able to provide informed consent and to participate in the clinical investigation or has a legally designated representative willing to provide informed consent on behalf of the DEU. Note, the legally designated representative and main CGR cannot be the same person.\n5. CGR is willing and able to provide informed consent to participate in the clinical investigation.\n6. The CGR frequently checks the saturation level of the incontinence product, manually and\u002For by a touch-feel process.\n7. If incontinence is managed by pharmaceuticals, the dose regime is stable.\n8. DEU and CGR ≥ 18 years of age.\n\nExclusion Criteria:\n\n1. DEU is cared for in a professional establishment or is institutionalized.\n2. DEU has ≥ 4 fecal \"incidences\" per week.\n3. DEU has severe incontinence product related skin problems, as judged by the investigator.\n4. DEU has any type of urinary catheter(s) resulting in improved\u002Ftreated urinary incontinence.\n5. The incontinence product is changed on a routine based on time (schedule) or device alert, without manual checks.\n6. Any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.\n7. CGR is incapable or unwilling to use the required smart phone application and\u002For the diary registration webpage required for the clinical investigation.\n8. Participation in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the course of the clinical investigation.\n9. DEU is pregnant or nursing.\n10. CGR or DEU with an alcohol or drug addiction",false,"ALL","18 Years",{"count":51,"type":52},35,"ACTUAL","INTERVENTIONAL",[55],"NA","The purpose of this post market clinical investigation is to demonstrate the performance and safety of the TENA SmartCare Change Indicator.",[58],"Urinary Incontinence","COMPLETED","2023-10-13",{"date":62,"type":52},"2024-04-08",{"date":64,"type":52},"2021-04-14",{"date":66,"type":52},"2021-10-28",{"name":5,"class":6},1]