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

NCT ID: NCT05357729

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-14
• Study Completion Date: 2022-09-02

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

MultiSense® remote monitoring

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.

Group Type: EXPERIMENTAL

MultiSense® remote monitoring

Intervention Type: DEVICE

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.

Interventions

MultiSense® remote monitoring

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rhythm Diagnostic Systems

INDUSTRY

Sponsor Role: collaborator

IHU Strasbourg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel VIX, MD

Role: PRINCIPAL_INVESTIGATOR

Service de Chirurgie Digestive, NHC, HUS

Locations

Service de Chirurgie Digestive et Endocrinienne

Strasbourg, , France

Countries

France

Other Identifiers

21-004

Identifier Type: -

Identifier Source: org_study_id