Informations générales (source: ClinicalTrials.gov)
Multicenter Clinical Investigation for the Evaluation of Safe Use of SECURIDRAP® SELFIA® (SECURIDRAP)
Interventional
N/A
Groupe Mulliez-Flory (Voir sur ClinicalTrials)
mai 2022
juillet 2025
21 novembre 2024
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Hospitalier d'Hazebrouck - Hazebrouck - France | Eddy Dr BAHEU | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Le Quesnoy - Le Quesnoy - France | Denis Dr LEFEBVRE | Contact (sur clinicalTrials) | |||
| CHG Roubaix - Roubaix - France | Pearlide Dr Kizonzolo-de-Bello | Contact (sur clinicalTrials) | |||
| CHU Lille - Lille - France | Francois Dr PUISIEUX | Contact (sur clinicalTrials) | |||
| CHU Lyon - Lyon - France | Sabiha Dr AHMINE | Contact (sur clinicalTrials) | |||
| CHU Rennes - Rennes - France | Aline Dr CORVOL | Contact (sur clinicalTrials) | |||
| CMMF de Bailleul - Bailleul - France | Brigitte Dr TILMONT | Contact (sur clinicalTrials) | |||
| CSSR La Clauze - Saint Jean Delnous - France | Philippe Dr VEAU | Contact (sur clinicalTrials) | |||
| EHPAD l'Aquarelle - Bully-les-Mines - France | Valérie Dr WIEL | Contact (sur clinicalTrials) | |||
| Ussap- Asm Limoux - Limoux - France | Brigitte Dr GERS | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- 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