Usability of SMART ANGEL Medical Device to Record and Transmit Health Data From Patient's Home Following Outpatient Surgery (SMART ANGEL 1)

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Surgery

Treatments

Device: issued with SMART ANGEL device

Study type

Interventional

Funder types

Other

Identifiers

NCT03464721

IDIL/2017/PC-01

2017-A02790-53 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

30 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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).