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SurgerySMART ANGEL 1NCT03464721

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

A study testing issued with SMART ANGEL device in people with Surgery, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Surgery
What is being tested?
issued with SMART ANGEL device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteFrance
Study dates
14 May 2018to 30 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Nimes

    Nîmes, 30029

Other trials in France

About this study

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

Conditions
Surgery
Being tested
issued with SMART ANGEL device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • issued with SMART ANGEL deviceDevice

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

Study groups in NCT03464721
Study groupRoleWhat they receive
Surgery OutpatientsExperimentalNot described
Receives: Device: issued with SMART ANGEL device

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Data collected and transmitted

    Measured: Day 0

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

    Data collected and transmitted

    Measured: Day 1

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

    Data collected and transmitted

    Measured: Day 2

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

    Data collected and transmitted

    Measured: Day 3

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

    Data collected and transmitted

    Measured: Day 4

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

    Data collected and transmitted

    Measured: Day 5

  7. Concordance between data collected on tablet versus paper copies

    Percentage correct measures

    Measured: Day 0

  8. Concordance between data collected on tablet versus paper copies

    Percentage correct measures

    Measured: Day 1

  9. Concordance between data collected on tablet versus paper copies

    Percentage correct measures

    Measured: Day 2

  10. Concordance between data collected on tablet versus paper copies

    Percentage correct measures

    Measured: Day 3

  11. Concordance between data collected on tablet versus paper copies

    Percentage correct measures

    Measured: Day 4

  12. Concordance between data collected on tablet versus paper copies

    Percentage correct measures

    Measured: Day 5

Secondary outcomes (4)

  1. Ease of use of medical device according to patient

    System Usability Scale (SUS) : score 0-100

    Measured: Day 5

  2. Qualitative decision-making ability from pooled results of all data from all patients

    Group of 2 experts decide whether patients should have been hospitalized, called, or left alone based on retrospective analysis of all data

    Measured: End of inclusion: Month 18

  3. Readmission rate

    Percentage of patients readmitted to hospital

    Measured: Month 1

  4. Qualitative decision-making ability from pooled results of all data from all patients on readmittance rate

    Group of 2 experts decide whether patients should have been readmitted based on retrospective analysis of all data

    Measured: End of inclusion period: Month 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2018
  2. Study start14 May 2018
  3. Primary completion30 Sep 2018
  4. Study completion30 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03464721
Sponsor's protocol ID
IDIL/2017/PC-01
Other IDs
2017-A02790-53
Acronym
SMART ANGEL 1
Status last verified
Jan 2019
First submitted
8 Mar 2018
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33032541

Questions about this trial

What is this clinical trial studying?

A study testing issued with SMART ANGEL device in people with Surgery, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation (time frame: Day 0). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03464721, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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