Objectives of the service
MELODY is a robotic telemedicine solution, which allows a medical expert to remotely perform an ultrasound exam on a distant patient in conditions very similar to conventional ultrasound. To date, while it has proven to be effective on adults already, children cannot benefit from this solution. Nevertheless, the needs are the same and some adjustments are necessary to make it suitable for paediatric use. This activity aims therefore to develop and validate a solution allowing children to also benefit from remote ultrasound scan. The activity includes a clinical trial carried out to evidence the benefits and support the application to CE marking required to bring the MELODY solution to the market.
Furthermore, with the challenges triggered by the Covid-19 health crisis, it is essential to promote tele-expertise solutions. MELODY is a valuable answer to respond to several problems:
- MELODY is an additional barrier to the spread of the virus, either by limited movement of contaminated or uncontaminated patients to specialised medical centres, and by allowing the medical expert to deliver diagnostics without direct exposure to contaminated patients,
- MELODY allows to benefit from a H24 examination by experts on duty,
- MELODY makes possible to carry out diseases screening and monitoring actions without exposing patients to radiation risks like for X-rays. Indeed, thoracic ultrasound appears in a number of publications to be a simple and rapid means of screening patients suspected of Covid-19.
Users and their needs
Ultrasound is widely used for children care because it is non-invasive and non-irradiating imaging technique. Medical desertification limits access to ultrasound for this population of patients, who is regularly transferred to another hospital or will get a scanner examination instead (very irradiating). Tele-ultrasound appears to be a relevant solution but still has to be validated for children.
For example, in the frame of this activity, the Centre Hospitalier Intercommunal de Créteil (CHIC), France, is the service user. The CHIC has the particularity to be a regional hospital hosting a reference centre for rare respiratory diseases. At the start of the Covid-19 health crisis, the CHIC rapidly faced the lack of paediatric experts able to perform ultrasound scans, which complicated the management of emergency situations.
The CHIC, like many other institutions facing the same problems, would need to have a solution that can be used for both adults and children offering the following advantages:
- Distribute expertise over a wide territory, remotely
- Get a second medical opinion faster and enhance long-distance cooperation
- Reduce waiting time before getting an ultrasound examination
- Reduce the need for patient transfer and improve patient care
- Reduce risks of contamination by limiting the spread of the virus.
- Avoid exposure to x-rays as ultrasound is non-ionizing technique, which can also be used for many pathologies.
Service/ system concept
The MELODY solution relies on robotized mechanical arm able to hold an ultrasound probe connected to an ultrasound machine. The arm is fully controllable remotely, so as to provide the expert sonographer with the ability to manipulate the probe in real time through an internet connection. Ultrasound images are transmitted from the patient site to the expert site through any form of telecommunication (it can be ground or satcom based). Thereby, MELODY helps make areas less isolated where there is a shortage of experts and improves patient care without moving the patient or the expert.
Figure 1 MELODY System Architecture
An expert site is linked to a patient site through an IT-Network:
- The expert site is equipped with one MELODY Expert System, one expert station and one videoconferencing station.
- The patient site is equipped with one MELODY Patient System, one ultrasound imaging station with a set of probes and one videoconferencing station.
Space Added Value
MELODY has been designed as a result of several years of R&D in the field of space medicine. The initial concept came from the need to be able to perform remote ultrasound scans on astronauts. The AdEchoTech company has born to transfer this technology to the Earth market and in 2015, CNES (French Agency for Space Studies) joined the company AdEchoTech as a shareholder.
Since 2012, AdEchoTech has been involved in several ESA projects:
- T4MOD - Telemedicine for reMote Operations in Distant areas,
- TESSA - Tele-Echography for ESA
- TRANSAT – TRANSlation capabilities for Advanced Tele-echography
- TETRIS - Tele-Echography Trade-off study for ISS
Within these projects, the ability to use the MELODY solution with a satcom system was successfully demonstrated.
Two complete MELODY Junior solutions have been installed in the premises of 2 hospitals in the Paris suburbs: the “Centre Hospitalier Intercommunal de Créteil” or CHIC and the “Centre Hospitalier intercommunal de Villeneuve Saint-Georges” or CHIV.
Figure 1 Expert site At CHIV
Figure 2 Patient site at CHIV
7 experts and 3 assistants were trained in the use of the device.
Figure 3 User training: Patient side
Figure 4 User training: Expert side
The clinical trial files have been submitted to the competent official authority, which has issued an approval for the performance of the clinical trial.
The first milestone of the project, the Design Review (DR) took place on January 12, 2021 and was successfully completed. The second milestone of the project, the Acceptance Review Milestone (AR) took place on 18 March 2021 and was also successfully completed. All the conditions necessary to start the pilot activities have been met and the clinical trial will start on 1 April 2021.