[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Groupe Mulliez-Flory\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"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":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100478471","evaluation-of-safe-use-of-securidrap-selfia-100478471",false,"NCT05510401","Evaluation of Safe Use of SECURIDRAP® SELFIA®","Multicenter Clinical Investigation for the Evaluation of Safe Use of SECURIDRAP® SELFIA®","SECURIDRAP","Inclusion Criteria:\n\n* Patient at least 18 years old\n* Patient having a medical prescription for SÉCURIDRAP® SELFIA®\n* Patient in phase or state of disorientation\n* Patient with nocturnal behavior disordre\n* Patient with major cognitive impairment\n* Patient at risk of falling into bed\n* Patient subject to guardianship or curatorship\n* Patient beneficiary or affiliated to a social security scheme\n* Patient who has given their participation agreement aand informed consent\n\nExclusion Criteria:\n\n* Patient and\u002For guardianship or curatorship refusing to agree to participate in the clinical investigation\n* Patient in psychiatry\n* Patient with severe agitation\n* Patient who will be agitated once installed in the SÉCURIDRAP® SELFIA®\n* Patient with intolerance to the medical device\n* Patient able to extract himself from SÉCURIDRAP® SELFIA®\n* Patient able to unlock the bed rails by himself\n* Patient without social coverage or not benefiting from it through a third party\n* Patient minor, pregnant woman, persons deprived of their liberty\n* Patient who participating or having participated in another clinical investigation, drug or medical device in the 30 days preceding inclusion","ALL","18 Years",{"count":20,"type":21},108,"ESTIMATED","INTERVENTIONAL",[24],"NA","Interventional, multicenter, prospective and non-comparative clinical investigation carried out in 9 French establishments in order to assess the safety of the SÉCURIDRAP® SELFIA® bedding by mesasuring all the adverse events likend to its use.\n\nFollowing the withdrawal from the market of the first version of the SECURIDRAP® SELFIA®, this clinical investigation is being carried out at the request and on the recommandation of the ASNM in order to assess the safety of the second version of the SECURIDRAP® SELFIA® coating.",[27,28,29],"Disorientation","Cognitive Impairment","Behavior Disorders",[31,32,33],"disorientation","nocturnal behavioral disorders","major cognitive impairment","RECRUITING","2024-11-19",{"date":37,"type":38},"2024-11-20","ACTUAL",{"date":40,"type":38},"2022-05-18",{"date":42,"type":21},"2025-07-30",{"name":44,"class":45},"Groupe Mulliez-Flory","INDUSTRY",10,""]