Actively Recruiting
Evaluation of Safe Use of SECURIDRAP® SELFIA®
Led by Groupe Mulliez-Flory · Updated on 2024-11-20
108
Participants Needed
10
Research Sites
167 weeks
Total Duration
On this page
Sponsors
G
Groupe Mulliez-Flory
Lead Sponsor
E
EVAMED
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Safe Use of SECURIDRAP® SELFIA®
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient at least 18 years old
- Patient having a medical prescription for SECURIDRAP® SELFIA®
- Patient in phase or state of disorientation
- Patient with nocturnal behavior disorder
- 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 and informed consent
You will not qualify if you...
- 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 SECURIDRAP® SELFIA®
- Patient with intolerance to the medical device
- Patient able to extract himself from SECURIDRAP® 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 is participating or has participated in another clinical investigation, drug or medical device in the 30 days preceding inclusion
AI-Screening
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Trial Site Locations
Total: 10 locations
1
CMMF de Bailleul
Bailleul, France
Actively Recruiting
2
EHPAD l'Aquarelle
Bully-les-Mines, France
Actively Recruiting
3
Centre Hospitalier d'Hazebrouck
Hazebrouck, France
Actively Recruiting
4
Centre Hospitalier Le Quesnoy
Le Quesnoy, France
Actively Recruiting
5
CHU Lille
Lille, France
Actively Recruiting
6
Ussap- Asm Limoux
Limoux, France
Actively Recruiting
7
CHU Lyon
Lyon, France
Actively Recruiting
8
CHU Rennes
Rennes, France
Actively Recruiting
9
CHG Roubaix
Roubaix, France
Actively Recruiting
10
CSSR La Clauze
Saint-Jean-Delnous, France
Actively Recruiting
Research Team
C
Céline BETOUX
CONTACT
K
Kelly LAVERGNE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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