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

NCT ID: NCT03464721

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-14

Study Completion Date

2018-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Surgery Outpatients

Group Type EXPERIMENTAL

issued with SMART ANGEL device

Intervention Type DEVICE

patients will use the technology at home to record and transmit data for blood pressure and oxygen saturation

Interventions

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issued with SMART ANGEL device

patients will use the technology at home to record and transmit data for blood pressure and oxygen saturation

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Cuvillon

Role: PRINCIPAL_INVESTIGATOR

CHU Nimes

Locations

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CHU Nimes

Nîmes, , France

Site Status

Countries

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France

References

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Chevallier T, Buzancais G, Occean BV, Rataboul P, Boisson C, Simon N, Lannelongue A, Chaniaud N, Gricourt Y, Lefrant JY, Cuvillon P. Feasibility of remote digital monitoring using wireless Bluetooth monitors, the Smart Angel app and an original web platform for patients following outpatient surgery: a prospective observational pilot study. BMC Anesthesiol. 2020 Oct 8;20(1):259. doi: 10.1186/s12871-020-01178-5.

Reference Type RESULT
PMID: 33032541 (View on PubMed)

Other Identifiers

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2017-A02790-53

Identifier Type: OTHER

Identifier Source: secondary_id

IDIL/2017/PC-01

Identifier Type: -

Identifier Source: org_study_id