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

December 16, 2025 updated by: Centre Hospitalier Universitaire de Nīmes
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes, France, 30029
        • CHU Nimes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Patients screened at CHU Nimes for consultation for preoperative anesthesia for surgery as an outpatient for foot, shoulder, gall bladder (cholecystectomy) or uterus (hysterectomy, ovariectomy).

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgery Outpatients
Device: issued with SMART ANGEL device
patients will use the technology at home to record and transmit data for blood pressure and oxygen saturation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation
Time Frame: Day 0
Data collected and transmitted
Day 0
Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation
Time Frame: Day 1
Data collected and transmitted
Day 1
Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation
Time Frame: Day 2
Data collected and transmitted
Day 2
Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation
Time Frame: Day 3
Data collected and transmitted
Day 3
Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation
Time Frame: Day 4
Data collected and transmitted
Day 4
Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation
Time Frame: Day 5
Data collected and transmitted
Day 5
Concordance between data collected on tablet versus paper copies
Time Frame: Day 0
Percentage correct measures
Day 0
Concordance between data collected on tablet versus paper copies
Time Frame: Day 1
Percentage correct measures
Day 1
Concordance between data collected on tablet versus paper copies
Time Frame: Day 2
Percentage correct measures
Day 2
Concordance between data collected on tablet versus paper copies
Time Frame: Day 3
Percentage correct measures
Day 3
Concordance between data collected on tablet versus paper copies
Time Frame: Day 4
Percentage correct measures
Day 4
Concordance between data collected on tablet versus paper copies
Time Frame: Day 5
Percentage correct measures
Day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of use of medical device according to patient
Time Frame: Day 5
System Usability Scale (SUS) : score 0-100
Day 5
Qualitative decision-making ability from pooled results of all data from all patients
Time Frame: End of inclusion: Month 18
Group of 2 experts decide whether patients should have been hospitalized, called, or left alone based on retrospective analysis of all data
End of inclusion: Month 18
Readmission rate
Time Frame: Month 1
Percentage of patients readmitted to hospital
Month 1
Qualitative decision-making ability from pooled results of all data from all patients on readmittance rate
Time Frame: End of inclusion period: Month 18
Group of 2 experts decide whether patients should have been readmitted based on retrospective analysis of all data
End of inclusion period: Month 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Philippe Cuvillon, CHU Nimes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2018

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

March 8, 2018

First Submitted That Met QC Criteria

March 8, 2018

First Posted (Actual)

March 14, 2018

Study Record Updates

Last Update Posted (Estimated)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • IDIL/2017/PC-01
  • 2017-A02790-53 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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