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Ambulatory SurgerySMART ANGEL 2NCT04068584

Evaluation of the Impact of the SMART ANGEL ™ Device on Follow-up at Home Following Major or Intermediate Outpatient Surgery

A study testing Smart Angel in people with Ambulatory Surgery, run by Centre Hospitalier Universitaire de Nīmes at 12 sites 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

The investigators hypothesize that by monitoring and analyzing physiological parameters (heart rate, blood pressure, saturation) and well-being (pain, nausea, vomiting, comfort) the SMART ANGEL ™ device improves the quality of care after major or intermediate outpatient surgery. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ambulatory Surgery
What is being tested?
Smart Angel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,260 participants
Where
12 sitesFrance
Study dates
3 Feb 2020to 18 Nov 2024
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 undergoing ambulatory surgery for:
  • in orthopedics: shoulder (arthroscopy, abutment, prosthesis), hip (prosthesis, arthrolysis), knee (osteotomy, ligamentoplasty), ankle (prosthesis, ligamentoplasty) foot (hallux valgus); removal of major or multi-site equipment;
  • digestive (cholecystectomy, hernia repair, partial gastrectomy, colectomy, cleaning);
  • in gynecology (hysterectomy, oophorectomy, mastectomy, quadrantectomy, dissection, cystoplasty, sphincter);
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  • in urology (total or partial resection of the prostate);
  • ENT (thyroidectomy, tonsillectomy);
  • Neurosurgery (herniated disc);
  • Vascular (stripping varix, creating fistula).
  • The patient has sufficient intellectual and cognitive capacity to use the devices
  • The patient must pass the test performed during the anesthesia consultation, namely:
  • open and connect the tablet,
  • activate the measurement of the blood pressure and the measurement of the oxygen saturation,
  • be connected to a 4G network

Who cannot join

  • The subject 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 is undergoing emergency or minor surgery
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  • Patient has a psychological class ASA 5
  • Patient is non-eligible for ambulatory surgery for medical reasons (decompensated medical pathology) or social reasons according to the criteria defined by the société française anesthésie réanimation. Person lives alone or has a geographical distance from a hospital center> 30 km (or> 45 min by car).
  • Patient who doesn't classify for ambulatory surgery at time of discharge

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • Clinique Bonnefon

    Alès, 30100

  • Centre hospitalier universitaire Amiens-Picardie

    Amiens, 80054

  • Hôpital Privé les Bonnettes

    Arras, 62000

  • Centre Hospitalier Henri Duffaut

    Avignon, 84000

  • CHU Lille

    Lille, 59000

  • Hopital Nord

    Marseille, 13915

  • Hôpital Lapeyronie

    Montpellier, 34090

  • CHU de Nimes

    Nîmes, 30029

  • Polyclinique Grand Sud

    Nîmes, 30900

  • Institut Mutualiste Montsouris

    Paris, 75674

  • CHU de Saint-Etienne

    Saint-Etienne, 42055

  • Clinique St Jean

    Saint-Jean-de-Védas, 34430

Other trials in France

About this study

Official title: Evaluation of the Impact of the SMART ANGEL ™ Device on Follow-up at Home Following Major or Intermediate Outpatient Surgery: Randomized Controlled Open-label Trial

The investigators hypothesize that by monitoring and analyzing physiological parameters (heart rate, blood pressure, saturation) and well-being (pain, nausea, vomiting, comfort) the SMART ANGEL ™ device improves the quality of care after major or intermediate outpatient surgery. This active surveillance will result in a decrease in the rate of unplanned recourse (hospitalization, consultation, telephone call).

Being tested
Smart Angel

What participants receive

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

  • Smart AngelOther

    Patient issued with a tablet with the Smart Angel application to monitor clinical signs and symptoms

Study groups in NCT04068584
Study groupRoleWhat they receive
Complete Smart AngelExperimentalSmat Angel application with artificial intelligence
Receives: Other: Smart Angel
Basic Smart AngelExperimentalSmat Angel application without artificial intelligence
Receives: Other: Smart Angel
ControlNo interventionNot described

What is being measured

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

  1. Non-scheduled hospitalization rates between groups

    %

    Measured: Day 5

  2. Number of non-scheduled consultations between groups

    %

    Measured: Day 5

  3. Rates of calls with nurses between groups

    %

    Measured: Day 5

  4. Rates of calls with doctors between groups

    %

    Measured: Day 5

  5. Rates of unplanned prescriptions between groups

    %

    Measured: Day 5

  6. Rates of unplanned exams between groups

    %

    Measured: Day 5

Secondary outcomes (14)

  1. Rate of complications between groups

    % patients reported any of: nausea, vomiting, constipation, allergy, shivering, insomnia, pain, fever, sore throat, lower back pain, headache, hypotension, bradycardia, hallucination, fainting, reopening of the incision, repeated surgery, abscess, bleeding, or bruising

    Measured: Day 1

  2. Rate of complications between groups

    % patients reported any of: nausea, vomiting, constipation, allergy, shivering, insomnia, pain, fever, sore throat, lower back pain, headache, hypotension, bradycardia, hallucination, fainting, reopening of the incision, repeated surgery, abscess, bleeding, or bruising

    Measured: Day 2

  3. Rate of complications between groups

    % patients reported any of: nausea, vomiting, constipation, allergy, shivering, insomnia, pain, fever, sore throat, lower back pain, headache, hypotension, bradycardia, hallucination, fainting, reopening of the incision, repeated surgery, abscess, bleeding, or bruising

    Measured: Day 3

  4. Rate of complications between groups

    % patients reported any of: nausea, vomiting, constipation, allergy, shivering, insomnia, pain, fever, sore throat, lower back pain, headache, hypotension, bradycardia, hallucination, fainting, reopening of the incision, repeated surgery, abscess, bleeding, or bruising

    Measured: Day 4

  5. Rate of complications between groups

    % patients reported any of: nausea, vomiting, constipation, allergy, shivering, insomnia, pain, fever, sore throat, lower back pain, headache, hypotension, bradycardia, hallucination, fainting, reopening of the incision, repeated surgery, abscess, bleeding, or bruising

    Measured: Day 5

  6. Rate of complications between groups

    % patients reported any of: nausea, vomiting, constipation, allergy, shivering, insomnia, pain, fever, sore throat, lower back pain, headache, hypotension, bradycardia, hallucination, fainting, reopening of the incision, repeated surgery, abscess, bleeding, or bruising

    Measured: Month 1

  7. Rate of readmission between groups

    Yes/No

    Measured: Month 1

  8. Date of return to work or other activity

    Dd/mm/yyyy

    Measured: 1 Month

  9. Patient satisfaction

    Visual Analog Scale 0-10

    Measured: Day 6

  10. Patient quality of life

    EQ-5D-5L questionnaire taken over the phone

    Measured: 1 month

  11. Difficulties in using the device

    In-house developed usage questionnaire assessing measurement difficulties, saving errors, connection problems, problem contacting care staff

    Measured: Day 5

  12. Requirement of external help in using the device

    Description of person sought for advice

    Measured: Day 5

  13. Times spent on device

    Hours; automatically calculated by device for time used for manipulation and time for navigation

    Measured: Day 5

  14. Technical errors arising

    Automatically calculated by device

    Measured: Day 5

Timeline

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

  1. First posted28 Aug 2019
  2. Study start3 Feb 2020
  3. Primary completion21 Oct 2024
  4. Study completion18 Nov 2024

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04068584
Sponsor's protocol ID
CIVI/2018/PC-01
Acronym
SMART ANGEL 2
Status last verified
May 2026
First submitted
22 Aug 2019
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Smart Angel in people with Ambulatory Surgery, run by Centre Hospitalier Universitaire de Nīmes at 12 sites 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 15 inclusion and 9 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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?

Non-scheduled hospitalization rates between groups (time frame: Day 5). The study lists 6 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 NCT04068584.

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 14 May 2026.

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