[{"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:":46},{"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":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":19,"type":20},108,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"Disorientation","Cognitive Impairment","Behavior Disorders",[30,31,32],"disorientation","nocturnal behavioral disorders","major cognitive impairment","RECRUITING","2024-11-19",{"date":36,"type":37},"2024-11-20","ACTUAL",{"date":39,"type":37},"2022-05-18",{"date":41,"type":20},"2025-07-30",{"name":43,"class":44},"Groupe Mulliez-Flory","INDUSTRY",10,""]