Ireland
--:--IST
Recruiting Not applicable

Evaluation of Safe Use of SECURIDRAP® SELFIA®

NCT05510401 · tracked via the Priya Life Science France tracker
Sponsor
Groupe Mulliez-Flory
Phase
Not applicable
Started
2022-05-18
Last updated
2024-11-20

Condition(s) studied

DisorientationCognitive ImpairmentBehavior Disorders

Investigational drug(s) / intervention(s)

SECURIDRAP® SELFIA®

SECURIDRAP® SELFIA®: Use of SECURIDRAP® SELFIA® for 15 night

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Rate of occurrence of adverse events related to the use of SÉCURIDRAP® SELFIA® — [15 days]
    quotient of the number of overnight stays or at least one adverse event related to the use of SÉCURIDRAP® SELFIA® appeared, by the number of overnight stays where SÉCURIDRAP® SELFIA® was used

Trial sites (10)

FacilityCityRegionStatus
CMMF de Bailleul Bailleul France Recruiting
EHPAD l'Aquarelle Bully-les-Mines France Recruiting
Centre Hospitalier d'Hazebrouck Hazebrouck France Recruiting
Centre Hospitalier Le Quesnoy Le Quesnoy France Recruiting
CHU Lille Lille France Recruiting
Ussap- Asm Limoux Limoux France Recruiting
CHU Lyon Lyon France Recruiting
CHU Rennes Rennes France Recruiting
CHG Roubaix Roubaix France Recruiting
CSSR La Clauze Saint-Jean-Delnous France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05510401 on ClinicalTrials.gov ↗ ← All trials in France