Evaluation of Safe Use of SECURIDRAP® SELFIA®
Recruiting now · Not applicable
Conditions studied: Disorientation, Cognitive Impairment, Behavior Disorders
In brief
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.
Key facts
- Study ID
- NCT05510401
- Run by
- Groupe Mulliez-Flory
- People needed
- 108
- Starts
- 2022-05-18
- Expected to finish
- 2025-07-30
- Last updated by the study team
- 2024-11-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- CMMF de Bailleul — Bailleul, France (enrolling)
- EHPAD l'Aquarelle — Bully-les-Mines, France (enrolling)
- Centre Hospitalier d'Hazebrouck — Hazebrouck, France (enrolling)
- Centre Hospitalier Le Quesnoy — Le Quesnoy, France (enrolling)
- CHU Lille — Lille, France (enrolling)
- Ussap- Asm Limoux — Limoux, France (enrolling)
- CHU Lyon — Lyon, France (enrolling)
- CHU Rennes — Rennes, France (enrolling)
- CHG Roubaix — Roubaix, France (enrolling)
- CSSR La Clauze — Saint-Jean-Delnous, France (enrolling)
Full record on ClinicalTrials.gov
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