Safety and Performance Study of the MultiSense® Ambulatory Telemonitoring System for Non-critical Patient Management (TELESENSE)

IHU Strasbourg

Status: Completed

Conditions: Visceral and Digestive Surgery; Post-surgical Monitoring; Post-surgical Rehabilitation

Treatments: Device: MultiSense® remote monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05357729

21-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult (male or female over 18 years) in non-critical care settings
2. Patient programmed for an elective surgery
3. Need to monitor at home at least one physiological parameter: heart rate, respiratory rate, SpO2, temperature, physical activity
4. Patient able to use a smartphone
5. Patient with Wi-Fi and/or Cellular connectivity at home
6. Patient with a personal phone which allows to receive text messages
7. Patient able to receive and understand information related to the study and give written informed consent
8. Patient affiliated to the French social security system

Exclusion criteria

1. Patient with known skin allergy (adhesive or silicon) or skin disease that would not allow the use of an adhesive
2. Patient with an active implantable device (such as a pacemaker or automatic defibrillator)
3. Patient with an elective imagery planned during the use of MultiSense
4. Pregnant or lactating patient
5. Patient in exclusion period (determined by a previous or a current study)
6. Patient under guardianship or trusteeship
7. Patient under the protection of justice or deprived of liberty
8. Patient in situation of emergency

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

MultiSense® remote monitoring

Experimental group

Description:

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.

Treatment:

Device: MultiSense® remote monitoring