NCT05357729

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: IHU Strasbourg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2022-06-14
• Primary completion: 2022-09-02
• Completion: 2022-09-02
• First posted: 2022-05-03
• Last updated: 2024-01-05

Locations

1 site across 1 country: France