Status:
RECRUITING
Evaluation of Safe Use of SECURIDRAP® SELFIA®
Lead Sponsor:
Groupe Mulliez-Flory
Collaborating Sponsors:
EVAMED
Conditions:
Disorientation
Cognitive Impairment
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 mesasurin...
Detailed Description
The proposed study is a prospective, multicenter, interventional and non-comparative research. This clinical investigation is carried out in real life in accordance with the usual care for all patien...
Eligibility Criteria
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
Exclusion Criteria:
- 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
Key Trial Info
Start Date :
May 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2025
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT05510401
Start Date
May 18 2022
End Date
July 30 2025
Last Update
November 20 2024
Active Locations (10)
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1
CMMF de Bailleul
Bailleul, France
2
EHPAD l'Aquarelle
Bully-les-Mines, France
3
Centre Hospitalier d'Hazebrouck
Hazebrouck, France
4
Centre Hospitalier Le Quesnoy
Le Quesnoy, France