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OpenTrials
Completed

NCT Number: NCT03464721

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

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

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

issued with SMART ANGEL device

Device

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

Primary outcomes

  1. Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation

    Time frame: Day 0

    Data collected and transmitted

  2. Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation

    Time frame: Day 1

    Data collected and transmitted

  3. Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation

    Time frame: Day 2

    Data collected and transmitted

  4. Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation

    Time frame: Day 3

    Data collected and transmitted

  5. Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation

    Time frame: Day 4

    Data collected and transmitted

  6. Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation

    Time frame: Day 5

    Data collected and transmitted

  7. Concordance between data collected on tablet versus paper copies

    Time frame: Day 0

    Percentage correct measures

  8. Concordance between data collected on tablet versus paper copies

    Time frame: Day 1

    Percentage correct measures

  9. Concordance between data collected on tablet versus paper copies

    Time frame: Day 2

    Percentage correct measures

  10. Concordance between data collected on tablet versus paper copies

    Time frame: Day 3

    Percentage correct measures

  11. Concordance between data collected on tablet versus paper copies

    Time frame: Day 4

    Percentage correct measures

  12. Concordance between data collected on tablet versus paper copies

    Time frame: Day 5

    Percentage correct measures

Secondary outcomes

  1. Ease of use of medical device according to patient

    Time frame: Day 5

    System Usability Scale (SUS) : score 0-100

  2. 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

  3. Readmission rate

    Time frame: Month 1

    Percentage of patients readmitted to hospital

  4. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: SMART ANGEL 1

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 14, 2018
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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