Status:

RECRUITING

Evaluation of Safe Use of SECURIDRAP® SELFIA®

Lead Sponsor:

Groupe Mulliez-Flory

Collaborating Sponsors:

EVAMED

Conditions:

Disorientation

Cognitive Impairment

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 mesasurin...

Detailed 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 patien...

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 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

Key Trial Info

Start Date :

May 18 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 30 2025

Estimated Enrollment :

108 Patients enrolled

Trial Details

Trial ID

NCT05510401

Start Date

May 18 2022

End Date

July 30 2025

Last Update

November 20 2024

Active Locations (10)

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Page 1 of 3 (10 locations)

1

CMMF de Bailleul

Bailleul, France

2

EHPAD l'Aquarelle

Bully-les-Mines, France

3

Centre Hospitalier d'Hazebrouck

Hazebrouck, France

4

Centre Hospitalier Le Quesnoy

Le Quesnoy, France

Evaluation of Safe Use of SECURIDRAP® SELFIA® | DecenTrialz