Visceral and Digestive SurgeryTELESENSENCT05357729
Safety and Performance Study of the MultiSense® Ambulatory Telemonitoring System for Non-critical Patient Management
A study testing MultiSense® remote monitoring in people with Visceral and Digestive Surgery and Post-surgical Monitoring, run by IHU Strasbourg at 1 site in France.
Trial summary
In this clinical investigation, the investigators will assess the safety, performances and clinical added value of the MultiSense® ambulatory telemonitoring solution in real-life situations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visceral and Digestive Surgery, Post-surgical Monitoring, Post-surgical Rehabilitation
- What is being tested?
- MultiSense® remote monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2022to 2 Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (male or female over 18 years) in non-critical care settings
- Patient programmed for an elective surgery
- Need to monitor at home at least one physiological parameter: heart rate, respiratory rate, SpO2, temperature, physical activity
- Patient able to use a smartphone
- Patient with Wi-Fi and/or Cellular connectivity at home
- Patient with a personal phone which allows to receive text messages
- Patient able to receive and understand information related to the study and give written informed consent
- Patient affiliated to the French social security system
Who cannot join
- Patient with known skin allergy (adhesive or silicon) or skin disease that would not allow the use of an adhesive
- Patient with an active implantable device (such as a pacemaker or automatic defibrillator)
- Patient with an elective imagery planned during the use of MultiSense
- Pregnant or lactating patient
- Patient in exclusion period (determined by a previous or a current study)
- Patient under guardianship or trusteeship
- Patient under the protection of justice or deprived of liberty
- Patient in situation of emergency
Trial locations and contacts
1 site in 1 country.
About this study
In this clinical investigation, the investigators will assess the safety, performances and clinical added value of the MultiSense® ambulatory telemonitoring solution in real-life situations.
Read the detailed description
The MultiSense® solution is a medical device for telemonitoring for in and outpatient use.
It includes 5 physiological data sensors and communicates via Bluetooth with a smartphone. The data is centralized in the web and a web application allows healthcare professionals to scrutinize patient's data.
Among its potential benefits, the MultiSense® solution offers continuous, non-invasive and wireless physiological data recording over 5 days whenever patient monitoring is needed. There is a special focus on the post-operative monitoring, especially during the initial convalescence phase outside the hospital. An automatic notification system can be set up by a healthcare professional to notify abnormal data and potential need for phone call and/or physical home intervention.
The aim of this study is to evaluate the safety, the performance and added value of the MultiSense® solution in real-life situations. The study population includes 20 post-surgical patients having a genuine need for post-hospital monitoring and be likely to have variations in physiological variables monitored, without being in a critical condition. The patients included will be equipped with the MultiSense® solution prior to the hospital discharge. The device will be used for 6 days from the date of actual deployment.
- Being tested
- MultiSense® remote monitoring
- Keywords
- Vital signs, Connected device, real-time monitoring, post-surgery monitoring, cardio-respiratory monitoring, telemonitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultiSense® remote monitoringDevice
At hospital, the patient will be monitored with conventional monitoring devices as well as the MultiSense® solution (at least one hour with a reference monitor). After hospital discharge, the patients will be remotely monitored by their healthcare professional using the MultiSense® solution.
| Study group | Role | What they receive |
|---|---|---|
| MultiSense® remote monitoring | Experimental | The patients included will be equipped with the MultiSense® solution prior to the hospital discharge. The device will be used for 6 days from the date of actual deployment. Receives: Device: MultiSense® remote monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of heart rate accuracy by comparison with a reference monitor.
Accuracy is defined as an average measurement variation less than 5 bpm of the mean value, with respect to the reference standard
Measured: From patch placement to hospital discharge, assessed up to 3 hours
Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of data availability.
Percentage of missing data due to technical issues (non-behavioral events) over the monitoring period below 15%.
Measured: From patch placement to removal, assessed up to 7 days
Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of data artefacts.
Percentage of artefacts due to technical issues (non-behavioral events) over the monitoring period below 10% for heart rate, 20% for the respiratory rate or 30% for SpO2.
Measured: From patch placement to removal, assessed up to 7 days
Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of data transmission.
Data transmission is defined as more than 90% of data with transmission time from patch to server less than 5 min.
Measured: From patch placement to removal, assessed up to 7 days
Secondary outcomes (13)
Patient's tolerance to prolonged use of the MultiSense® solution (Safety in use, side effects)
Accounting and classification of unexpected local and distant event due to the use of the MultiSense® solution (vigilance data) and Patient's questionnaire
Measured: From patch placement to its removal (up to 7 days)
Device defects
Accounting of device deficiencies reported by the investigator, the patient or identified by MultiSense data analysis
Measured: From patch placement to its removal (up to 7 days)
Clinical relevance of the notifications provided by MultiSense® solution
Relevance of the notifications generated by MultiSense® will be judged on the relevance of the notification's functionality by the healthcare professional in real-life situation by the mean of a questionnaire (4-levels Likert scale)
Measured: From patch placement to its removal (up to 7 days)
Clinical relevance of the notifications provided by MultiSense® solution
Relevance of the notifications generated by MultiSense® will be judged on the relevance of the notification's functionality by the healthcare professional in real-life situation by the mean of notification treatment through MultiSense® web application
Measured: From patch placement to its removal (up to 7 days)
Remote monitoring facilitation for the healthcare professional through the solution's ease of use and satisfaction gained
Determination of healthcare professionals' practical interest in the solution and satisfaction of use assessed via a questionnaire (4-levels Likert scale)
Measured: From patch placement to its removal (up to 7 days)
Patient's satisfaction and reassurance when monitored by the device
Determination of patient satisfaction and reassurance by an end-study questionnaire (4-levels Likert scale)
Measured: From patch placement to its removal (up to 7 days)
Patch autonomy
Percentage of patches with an autonomy > 5 days including skin adhesion and battery life (MultiSense® data and patient's questionnaire)
Measured: From patch placement to its removal (up to 7 days)
Respiratory rate accuracy in terms of impedance
Respiratory rate accuracy by comparison of MultiSense® data with the reference monitor in terms of impedance
Measured: From patch placement to hospital discharge, assessed up to 3 hours
Respiratory rate accuracy in terms of EtCO2
Respiratory rate accuracy by comparison of MultiSense® data with the reference monitor in terms of EtCO2
Measured: From patch placement to hospital discharge, assessed up to 3 hours
Estimation of posture and activity level reported by the MultiSense® solution
Determination of the posture and activity level consistency by accounting the percentage of lying position and low activity at night and the percentage of high activity during day (MultiSense® data)
Measured: From patch placement to its removal (up to 7 days)
MultiSense® data quality after moderate level of activity
Distribution of activity level across monitoring period, number of showers taken over the monitoring period and evolution of the artefact's metric (as defined in the primary endpoint) over time (MultiSense® data)
Measured: From patch placement to its removal (up to 7 days)
Correlation between body temperature and skin temperature
Correlation between the body temperature measured with a standard device and the skin temperature measured with the MultiSense® solution
Measured: From patch placement to hospital discharge, assessed up to 2 days
End of study hardware recovery rate
Percentage of MultiSense® patch and gateway returned to RDS at the end of the study
Measured: From patch removal to material return, assessed up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start14 Jun 2022
- Primary completion2 Sep 2022
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral and Digestive SurgeryStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Collaborators
- Rhythm Diagnostic Systems
- Responsible party
- Sponsor
- Investigators
- Michel VIX, MD, Principal investigator, Service de Chirurgie Digestive, NHC, HUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357729
- Sponsor's protocol ID
- 21-004
- Acronym
- TELESENSE
- Status last verified
- Jan 2024
- First submitted
- 27 Apr 2022
- Last updated
- 5 Jan 2024
- 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 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Study of the MultiSense® Ambulatory Telemonitoring System for Non-critical Patient Management
- ClinicalTrials.gov ID
- NCT05357729
- Acronym / sponsor ID
- TELESENSE / 21-004
- Keywords
- Vital signs, Connected device, real-time monitoring, post-surgery monitoring, cardio-respiratory monitoring, telemonitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Collaborators
- Rhythm Diagnostic Systems
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 3 May 2022 (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.
In this clinical investigation, the investigators will assess the safety, performances and clinical added value of the MultiSense® ambulatory telemonitoring solution in real-life situations.
Detailed description
The MultiSense® solution is a medical device for telemonitoring for in and outpatient use.
It includes 5 physiological data sensors and communicates via Bluetooth with a smartphone. The data is centralized in the web and a web application allows healthcare professionals to scrutinize patient's data.
Among its potential benefits, the MultiSense® solution offers continuous, non-invasive and wireless physiological data recording over 5 days whenever patient monitoring is needed. There is a special focus on the post-operative monitoring, especially during the initial convalescence phase outside the hospital. An automatic notification system can be set up by a healthcare professional to notify abnormal data and potential need for phone call and/or physical home intervention.
The aim of this study is to evaluate the safety, the performance and added value of the MultiSense® solution in real-life situations. The study population includes 20 post-surgical patients having a genuine need for post-hospital monitoring and be likely to have variations in physiological variables monitored, without being in a critical condition. The patients included will be equipped with the MultiSense® solution prior to the hospital discharge. The device will be used for 6 days from the date of actual deployment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MultiSense® remote monitoring | Experimental | Device: MultiSense® remote monitoringThe patients included will be equipped with the MultiSense® solution prior to the hospital discharge. The device will be used for 6 days from the date of actual deployment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult (male or female over 18 years) in non-critical care settings
- Patient programmed for an elective surgery
- Need to monitor at home at least one physiological parameter: heart rate, respiratory rate, SpO2, temperature, physical activity
- Patient able to use a smartphone
- Patient with Wi-Fi and/or Cellular connectivity at home
Key exclusion criteria (8 listed)
- Patient with known skin allergy (adhesive or silicon) or skin disease that would not allow the use of an adhesive
- Patient with an active implantable device (such as a pacemaker or automatic defibrillator)
- Patient with an elective imagery planned during the use of MultiSense
- Pregnant or lactating patient
- Patient in exclusion period (determined by a previous or a current study)
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 |
|---|---|---|
| MultiSense® remote monitoringAt hospital, the patient will be monitored with conventional monitoring devices as well as the MultiSense® solution (at least one hour with a reference monitor). After hospital discharge, the patients will be remotely monitored by their healthcare professional using the MultiSense® solution. | Device | MultiSense® remote monitoring |
Primary outcome
Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of heart rate accuracy by comparison with a reference monitor.
Time frame: From patch placement to hospital discharge, assessed up to 3 hours
Accuracy is defined as an average measurement variation less than 5 bpm of the mean value, with respect to the reference standard
Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of data availability.
Time frame: From patch placement to removal, assessed up to 7 days
Percentage of missing data due to technical issues (non-behavioral events) over the monitoring period below 15%.
Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of data artefacts.
Time frame: From patch placement to removal, assessed up to 7 days
Percentage of artefacts due to technical issues (non-behavioral events) over the monitoring period below 10% for heart rate, 20% for the respiratory rate or 30% for SpO2.
Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of data transmission.
Time frame: From patch placement to removal, assessed up to 7 days
Data transmission is defined as more than 90% of data with transmission time from patch to server less than 5 min.
13 secondary outcomes
Patient's tolerance to prolonged use of the MultiSense® solution (Safety in use, side effects)
Time frame: From patch placement to its removal (up to 7 days)
Device defects
Time frame: From patch placement to its removal (up to 7 days)
Clinical relevance of the notifications provided by MultiSense® solution
Time frame: From patch placement to its removal (up to 7 days)
Clinical relevance of the notifications provided by MultiSense® solution
Time frame: From patch placement to its removal (up to 7 days)
Remote monitoring facilitation for the healthcare professional through the solution's ease of use and satisfaction gained
Time frame: From patch placement to its removal (up to 7 days)
Patient's satisfaction and reassurance when monitored by the device
Time frame: From patch placement to its removal (up to 7 days)
Patch autonomy
Time frame: From patch placement to its removal (up to 7 days)
Respiratory rate accuracy in terms of impedance
Time frame: From patch placement to hospital discharge, assessed up to 3 hours
Respiratory rate accuracy in terms of EtCO2
Time frame: From patch placement to hospital discharge, assessed up to 3 hours
Estimation of posture and activity level reported by the MultiSense® solution
Time frame: From patch placement to its removal (up to 7 days)
MultiSense® data quality after moderate level of activity
Time frame: From patch placement to its removal (up to 7 days)
Correlation between body temperature and skin temperature
Time frame: From patch placement to hospital discharge, assessed up to 2 days
End of study hardware recovery rate
Time frame: From patch removal to material return, assessed up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- 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. This study is not recruiting at the moment.
Michel VIX, MD principal investigator
Service de Chirurgie Digestive, NHC, HUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MultiSense® remote monitoring in people with Visceral and Digestive Surgery and Post-surgical Monitoring, run by IHU Strasbourg 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 8 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 5 Jan 2024. 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?
Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of heart rate accuracy by comparison with a reference monitor. (time frame: From patch placement to hospital discharge, assessed up to 3 hours). The study lists 4 primary outcomes in all. 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 5 Jan 2024.