BridgeMD
New treatment option for Disorientation
Official title Evaluation of Safe Use of SECURIDRAP® SELFIA®
ClinicalTrials.gov ID: NCT05510401
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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®
See the full eligibility 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 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
The study team makes the final eligibility decision.
Where it's taking place
- Bailleul, France
- Bully-les-Mines, France
- Hazebrouck, France
- Le Quesnoy, France
- Lille, France
- Limoux, France
- Lyon, France
- Rennes, France
- Roubaix, France
- Saint-Jean-Delnous, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bailleul, France; Bully-les-Mines, France; Hazebrouck, France; Le Quesnoy, France; Lille, France; Limoux, France and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.