Average Length of StayIMPACT - MSNCT07514286
Assessment of the Feasibility and Organisational Impact of a Care Pathway Incorporating the MultiSense® Medical Device for Post-operative Home Monitoring of Elderly Patients.
A study testing Monitoring by MultiSense in people with Average Length of Stay and Surgery, run by Rhythm Diagnostic Systems at 4 sites in France.
Trial summary
Assessing the clinical and organisational impact of a home-based post-operative monitoring strategy incorporating the MultiSense® device involving 80 patients aged 65 years and over who have undergone major surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Average Length of Stay, Surgery
- What is being tested?
- Monitoring by MultiSense
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesFrance
- Study dates
- 3 Jun 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient aged 65 or over
- Patient eligible for remote monitoring using the MultiSense® device
- No psychiatric illness that would prevent them from giving informed consent or receiving optimal treatment and follow-up care
- Subject affiliated with a health insurance scheme
- Subject able to read and understand English
- Subject who has signed an informed consent form
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- Subjects indicated for scheduled surgery
- Patients indicated for scheduled surgery :
- Transverse colectomy, by laparotomy
- Hepatic laparoscopy
- Laparoscopic or laparoscopic liver surgery (code hlfc or hlfa for procedures)
- Hysterectomy
- Adnexectomy
- Parietal surgery (eventration)
- Rectal resection
- Right and left colectomy
- Stoma closure by direct approach
Who cannot join
- Patients already participating in an interventional clinical trial.
- Patients subject to legal protection measures, guardianship, curatorship, or deprived of their liberty by judicial or administrative decision.
- Patients hospitalised without consent.
- Patients unable to complete a questionnaire and without a close relative to assist them in using the solution.
- Patients admitted to or residing in a health or social care facility (other than for the surgery itself).
- Persons admitted to or residing in a health or social care institution (other than for the surgery itself);
- Persons unable to give their free and informed consent.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Western Cancer Institute of Angers
Angers, 49000
Dr Augustin REYNARD, Gynaecological Oncology Surgeon, +33 2 41 35 29 02, augustin.reynard@ico.unicancer.fr
- Not yet recruiting
Bergonié Insititute
Bordeaux, 33000
Dr Brice RICHEZ, Anaesthetist and intensive care specialist, +33 5 56 33 32 40, b.richez@bordeaux.unicancer.fr
- Not yet recruiting
Inter-municipal Hospital Centre of Mont-de-marsan
Mont-de-Marsan, 40000
Dr Rémy CHEVALIER, Visceral and digestive surgeon, +33 5 58 05 10 09, remy.chevalier@ch-mdm.fr
- Recruiting
Western Cancer Institute of Nantes
Nantes, 44000
Dr Timothée VIGNAUD, Visceral and digestive surgeon, +33 2 40 67 99 00, Timothee.vignaud@ico.unicancer.fr
About this study
Assessing the clinical and organisational impact of a home-based post-operative monitoring strategy incorporating the MultiSense® device involving 80 patients aged 65 years and over who have undergone major surgery.
Read the detailed description
Evaluate the clinical and organisational impact of a post-operative home monitoring strategy incorporating the MultiSense® device in elderly patients.
The study will be conducted in a multicentre setting, involving 80 patients aged 65 years and over who have undergone major surgery.
- Conditions
- Average Length of Stay, Surgery
- Being tested
- Monitoring by MultiSense
- Keywords
- Remote monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring by MultiSenseDevice
The MultiSense device will be placed on the patient's back and will allow physicians to remotely monitor six biological parameters
| Study group | Role | What they receive |
|---|---|---|
| MS | Experimental | All patients will be monitored at home with the medical device MultiSense® Receives: Device: Monitoring by MultiSense |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients whose care was deemed satisfactory
The quality of surgical care will be assessed using a "textbook outcome" (TO) composed of the 2 following criteria :
- A shorter-than-average stay (below the 75th percentile).
- No emergency readmission or ER visit within 7 days of going home."
Measured: 7 days
Secondary outcomes (16)
Average length of initial hospital stay following surgery
Measured: 7 days
Percentage of patients requiring unscheduled care related to surgery at 30 days
Patients requiring unplanned readmission and/or a visit to the emergency department
Measured: 30 days
Percentage of patients with at least one unplanned rehospitalization following telemonitoring and at 30 days
Measured: 30 days
Percentage of patients with at least one visit to the emergency department following telemonitoring and at day 30
Measured: 30 days
Percentage of patients with at least one grade 3 to 5 complication according to the Clavien-Dindo classification at 30 days
The Clavien-Dindo classification is a system used in surgery to classify postoperative complications according to their severity
Measured: 30 days
Number of unplanned rehospitalizations and/or emergency department visits at 30 days (total and per patient)
Measured: 30 days
Number of unscheduled visits (to a general practitioner or a surgeon) at 30 days (total and per patient)
Measured: 30 days
Quality of postoperative recovery using the French version of the fQoR-15 scale at hospital discharge (V2) and at 30 days (V4)
Assess the impact on patient's quality of life fQoR-15 : French Quality of Recovery-15 15 : corresponds to the 15 multidimensional questions that make up the score. The total score ranges from 0 to 150 The higher the score, the better the quality of post-operative recovery High score = optimal recovery Low score = impaired recovery
Measured: 30 days
Measurement of the overall index score for the EQ-5D-5L questionnaire at preoperative assessment (V0), at hospital discharge (V2), and at 30 days (V4)
Assess the impact on patients' quality of life
EQ : EuroQol, the name of the international research group that developed this tool.
5D : 5 dimensions of health assessed (mobility, independence, daily activities, pain/discomfort, and anxiety/depression).
5L : 5 levels, the 5 possible severity levels for each dimension :
- Level 1 : No difficulty (or no problems).
- Level 2 : Mild problems.
- Level 3 : Moderate problems.
- Level 4 : Severe problems.
- Level 5 : Total disability (or extreme problems). A higher score indicates better health
Measured: 30 days
Total length of hospital stay (initial admission and readmission) at 30 days
Assess the organizational impact associated with the deployment of the MULTISENSE® solution based on the HAS's mapping
Measured: 30 days
DAOH30 (Days Alive and Out of Hospital) or Days of Independence at Home at Day 30, defined as the number of days during which the patient recovered independently at home without requiring hospitalization or rehospitalization, during the 30-day postoper
This outcome will be calculated using the following formula :
DAOH30 = 30 days - (initial length of stay + duration of readmissions)
Measured: 30 days
Percentage of patients who did not comply with remote monitoring via MultiSense® (non-compliance is defined as the patient discontinuing monitoring before reaching 80% of the scheduled duration, which corresponds to the 4th day)
Assess patient and healthcare professional satisfaction with and usability of the solution
Measured: 4th day
Average usability score reported by healthcare professionals using the French version of the SUS (System Usability Scale) questionnaire completed at the end of the study
SUS : System Usability Scale Minimum value : 0 Maximum value : 100
Interpretation of the score :
A high score indicates a positive result. The closer the score is to 100, the more the system (in this case, the MultiSense® solution) is considered to be user-friendly, intuitive and satisfactory for healthcare professionals. Conversely, a low score indicates poor usability.
Measured: 8 months
Level of patient satisfaction as measured by a specific questionnaire completed following the remote monitoring session
This is an 'ad hoc' satisfaction questionnaire (specifically designed for the purposes of this study).
Scale details : The full name given in the appendix is the Patient Satisfaction Questionnaire. It assesses levels of satisfaction with the MultiSense® solution. Scores and interpretation : the exact minimum and maximum scores are not specified, a high score corresponds to a positive result (greater patient satisfaction).
Measured: 5th day
Level of healthcare professionals' reassurance regarding the patient's return home, assessed by a questionnaire completed at the time of discharge.
This is an 'ad hoc' satisfaction questionnaire (specifically designed for the purposes of this study).
Scale details : The full name given in the appendix is the Patient Satisfaction Questionnaire. It assesses levels of satisfaction with the MultiSense® solution. Scores and interpretation : the exact minimum and maximum scores are not specified, a high score corresponds to a positive result (greater patient satisfaction).
Measured: Day 1
Level of satisfaction among healthcare professionals, as measured by a specific questionnaire completed at the end of the study
This is an 'ad hoc' satisfaction questionnaire (specifically designed for the purposes of this study).
Scale details : The full name given in the appendix is the Patient Satisfaction Questionnaire. It assesses levels of satisfaction with the MultiSense® solution. Scores and interpretation : the exact minimum and maximum scores are not specified, a high score corresponds to a positive result (greater patient satisfaction).
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start3 Jun 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Average Length of StayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhythm Diagnostic Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514286
- Sponsor's protocol ID
- 2025 - 02
- Other IDs
- N° IDRCB: 2025-A02326-43
- Acronym
- IMPACT - MS
- Status last verified
- Jun 2026
- First submitted
- 24 Mar 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Feasibility and Organisational Impact of a Care Pathway Incorporating the MultiSense® Medical Device for Post-operative Home Monitoring of Elderly Patients.
- ClinicalTrials.gov ID
- NCT07514286
- Acronym / sponsor ID
- IMPACT - MS / 2025 - 02
- Conditions
- Average Length of Stay, Surgery
- Keywords
- Remote monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rhythm Diagnostic SystemsIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessing the clinical and organisational impact of a home-based post-operative monitoring strategy incorporating the MultiSense® device involving 80 patients aged 65 years and over who have undergone major surgery.
Detailed description
Evaluate the clinical and organisational impact of a post-operative home monitoring strategy incorporating the MultiSense® device in elderly patients.
The study will be conducted in a multicentre setting, involving 80 patients aged 65 years and over who have undergone major surgery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MS | Experimental | Device: Monitoring by MultiSenseAll patients will be monitored at home with the medical device MultiSense® |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (17 listed)
- Patient aged 65 or over
- Patient eligible for remote monitoring using the MultiSense® device
- No psychiatric illness that would prevent them from giving informed consent or receiving optimal treatment and follow-up care
- Subject affiliated with a health insurance scheme
- Subject able to read and understand English
Key exclusion criteria (7 listed)
- Patients already participating in an interventional clinical trial.
- Patients subject to legal protection measures, guardianship, curatorship, or deprived of their liberty by judicial or administrative decision.
- Patients hospitalised without consent.
- Patients unable to complete a questionnaire and without a close relative to assist them in using the solution.
- Patients admitted to or residing in a health or social care facility (other than for the surgery itself).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring by MultiSenseThe MultiSense device will be placed on the patient's back and will allow physicians to remotely monitor six biological parameters | Device | MS |
Primary outcome
The percentage of patients whose care was deemed satisfactory
Time frame: 7 days
The quality of surgical care will be assessed using a "textbook outcome" (TO) composed of the 2 following criteria : 1. A shorter-than-average stay (below the 75th percentile). 2. No emergency readmission or ER visit within 7 days of going home."
16 secondary outcomes
Average length of initial hospital stay following surgery
Time frame: 7 days
Percentage of patients requiring unscheduled care related to surgery at 30 days
Time frame: 30 days
Percentage of patients with at least one unplanned rehospitalization following telemonitoring and at 30 days
Time frame: 30 days
Percentage of patients with at least one visit to the emergency department following telemonitoring and at day 30
Time frame: 30 days
Percentage of patients with at least one grade 3 to 5 complication according to the Clavien-Dindo classification at 30 days
Time frame: 30 days
Number of unplanned rehospitalizations and/or emergency department visits at 30 days (total and per patient)
Time frame: 30 days
Number of unscheduled visits (to a general practitioner or a surgeon) at 30 days (total and per patient)
Time frame: 30 days
Quality of postoperative recovery using the French version of the fQoR-15 scale at hospital discharge (V2) and at 30 days (V4)
Time frame: 30 days
Measurement of the overall index score for the EQ-5D-5L questionnaire at preoperative assessment (V0), at hospital discharge (V2), and at 30 days (V4)
Time frame: 30 days
Total length of hospital stay (initial admission and readmission) at 30 days
Time frame: 30 days
DAOH30 (Days Alive and Out of Hospital) or Days of Independence at Home at Day 30, defined as the number of days during which the patient recovered independently at home without requiring hospitalization or rehospitalization, during the 30-day postoper
Time frame: 30 days
Percentage of patients who did not comply with remote monitoring via MultiSense® (non-compliance is defined as the patient discontinuing monitoring before reaching 80% of the scheduled duration, which corresponds to the 4th day)
Time frame: 4th day
Average usability score reported by healthcare professionals using the French version of the SUS (System Usability Scale) questionnaire completed at the end of the study
Time frame: 8 months
Level of patient satisfaction as measured by a specific questionnaire completed following the remote monitoring session
Time frame: 5th day
Level of healthcare professionals' reassurance regarding the patient's return home, assessed by a questionnaire completed at the time of discharge.
Time frame: Day 1
Level of satisfaction among healthcare professionals, as measured by a specific questionnaire completed at the end of the study
Time frame: 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Inter-municipal Hospital Centre of Mont-de-marsan
Mont-de-Marsan, France
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring by MultiSense in people with Average Length of Stay and Surgery, run by Rhythm Diagnostic Systems at 4 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 17 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients whose care was deemed satisfactory (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2026.