Evaluation of Safe Use of SECURIDRAP® SELFIA®
Multicenter Clinical Investigation for the Evaluation of Safe Use of SECURIDRAP® SELFIA®
Groupe Mulliez-Flory
108 participants
May 18, 2022
INTERVENTIONAL
Conditions
Summary
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. Following 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.
Eligibility
Inclusion Criteria9
- Patient at least 18 years old
- Patient having a medical prescription for SÉCURIDRAP® SELFIA®
- Patient in phase or state of disorientation
- Patient with nocturnal behavior disordre
- Patient with major cognitive impairment
- Patient at risk of falling into bed
- Patient subject to guardianship or curatorship
- Patient beneficiary or affiliated to a social security scheme
- Patient who has given their participation agreement aand informed consent
Exclusion Criteria10
- Patient and/or guardianship or curatorship refusing to agree to participate in the clinical investigation
- Patient in psychiatry
- Patient with severe agitation
- Patient who will be agitated once installed in the SÉCURIDRAP® SELFIA®
- Patient with intolerance to the medical device
- Patient able to extract himself from SÉCURIDRAP® SELFIA®
- Patient able to unlock the bed rails by himself
- Patient without social coverage or not benefiting from it through a third party
- Patient minor, pregnant woman, persons deprived of their liberty
- Patient who participating or having participated in another clinical investigation, drug or medical device in the 30 days preceding inclusion
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Interventions
Use of SECURIDRAP® SELFIA® for 15 night
Locations(10)
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NCT05510401