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Status:

COMPLETED

Usability of SMART ANGEL Medical Device to Record and Transmit Health Data From Patient's Home Following Outpatient Surgery

Lead Sponsor:

Centre Hospitalier Universitaire de Nīmes

Conditions:

Surgery

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

This study represents the first step for testing this device in patients in real-life situations to evaluate the technological capacities and usability by the patient

Eligibility Criteria

Inclusion

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient is at least 18 years old and less than 80 years old
  • The patient is undergoing orthopedic (shoulder, foot, knee), digestive (gallbladder) or gynecological (uterus-ovary) adjustment outpatient surgery
  • The patient has sufficient cognitive and intellectual ability to use the system
  • The patient must undergo a training test during consultation to use the tablet and perform the measurements
  • The patient must have access to 4G at home.

Exclusion

  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • The patient is pregnant
  • The patient needs emergency surgery
  • The patient has a level 4 or 5 ASA psychological class
  • Patient cannot have outpatient surgery for medical reasons (decompensated medical pathology), or social reasons according the the SFAR (société française anesthésie réanimation) criteria. Patient alone at home and geographically far from a hospital \>30km (or \>45 minutes by car).

Key Trial Info

Start Date :

May 14 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 30 2018

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT03464721

Start Date

May 14 2018

End Date

September 30 2018

Last Update

December 22 2025

Active Locations (1)

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1

CHU Nimes

Nîmes, France, 30029