Evaluation of Safe Use of SECURIDRAP® SELFIA®

Last updated: November 19, 2024
Sponsor: Groupe Mulliez-Flory
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mild Cognitive Impairment

Dementia

Learning Disorders

Treatment

SECURIDRAP® SELFIA®

Clinical Study ID

NCT05510401
2019-A03234-53
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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

Exclusion Criteria:

  • Patient and/or guardianship or curatorship refusing to agree to participate in theclinical 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

Study Design

Total Participants: 108
Treatment Group(s): 1
Primary Treatment: SECURIDRAP® SELFIA®
Phase:
Study Start date:
May 18, 2022
Estimated Completion Date:
July 30, 2025

Study 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 patient with a prescription for SECURIDRAP® SELFIA® and who meet the eligibility criteria, in nursing homes and public and private hospitals based in France.

This interventional clinical investigation with minimal risks and constraints aims to confirm the safety of use of SECURIDRAP® SELFIA® in healthcare establishment.

The patient will be followed for 15 nigths, during witch an independent assessor will ensure that the conditions of use os the SECURIDRAP® SELFIA® sleeping bag are respected.

Connect with a study center

  • François PUISIEUX

    Lille, Nord 59000
    France

    Active - Recruiting

  • CMMF de Bailleul

    Bailleul,
    France

    Active - Recruiting

  • EHPAD l'Aquarelle

    Bully-les-Mines,
    France

    Active - Recruiting

  • Centre Hospitalier d'Hazebrouck

    Hazebrouck,
    France

    Active - Recruiting

  • Centre Hospitalier Le Quesnoy

    Le Quesnoy,
    France

    Active - Recruiting

  • CHU Lille

    Lille,
    France

    Active - Recruiting

  • Ussap- Asm Limoux

    Limoux,
    France

    Active - Recruiting

  • CHU Lyon

    Lyon,
    France

    Active - Recruiting

  • CHU Rennes

    Rennes,
    France

    Active - Recruiting

  • CHG Roubaix

    Roubaix,
    France

    Active - Recruiting

  • CSSR La Clauze

    Saint Jean Delnous,
    France

    Active - Recruiting

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