Evaluation of Safe Use of SECURIDRAP® SELFIA®
Recruiting
N/A
Interventional Study
Disorientation
Cognitive Impairment
Behavior Disorders
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 108 (estimated)
- Sponsor
- Groupe Mulliez-Flory · Industry
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About This Trial
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 a…
Trial Locations
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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 subj…
Contacts