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Efficacy and Tolerance of Telerobotic vs Standard Ultrasound Exam in Children

NCT ID: NCT04776174

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-11-03

Brief Summary

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In children with Covid-19, the diagnosis of Kawasaki Disease (KD) and pneumonia should be made very quickly. However, the regional hospitals surrounding Paris don't have the required expertise. The use of MELODY allows the paediatric team to quickly carry out the necessary examinations while avoiding the movement of patients and the risk of contamination.

The MELODY remote system developed by the company AdEchoTech is a CE marking telemedicine technique, allowing an expert to perform an ultrasound scan on a distant patient (several hundred/thousands of kms). The Melody system makes it possible to optimize ultrasound expertise resources wherever they are located (all specialties combined) The feasibility of the clinical use of telerobotic sonography has been demonstrated in adults for abdominal, cardiac and prenatal exam. Thus, the aim of this study is to assess the feasibility of this system in children.

Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Children will be initially scanned with a telerobotic ultrasound system. Within 3 hours after the telerobotic examination, patients will be scanned by a different sonographer with similar experience and qualifications using the conventional ultrasound, who will be blinded to the findings of the telerobotic examination.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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standard and telerobotic ultrasound

Included patients will have both ultrasound examination: standard ultraosound (abdominal, cardiac or pulmonary depending on the prescription and telerobotic ultrasound

Group Type EXPERIMENTAL

Ultrasound using the telerobotic Melody system

Intervention Type DEVICE

The children will first have a telerobotic ultrasound abdominal, pulmonary or cardiac followed by a classical ultrasound.

Interventions

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Ultrasound using the telerobotic Melody system

The children will first have a telerobotic ultrasound abdominal, pulmonary or cardiac followed by a classical ultrasound.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient from 1 year to 10 years
* Patient requiring an ultrasound exam (thoracic, abdominal or cardiac)
* French social security affiliation

Exclusion Criteria

* Obesity defined by a BMI greater than 30
* Open wound making it impossible to carry out an ultrasound scan
* Algetic patient
* Instability of vital functions
* Impossible to remain in a seated position
* Refusal to participate in the study
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ADECHOTECH

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHI Créteil

Créteil, , France

Site Status

CHI Villeneuve-Saint-Georges

Villeneuve-Saint-Georges, , France

Site Status

Countries

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France

Other Identifiers

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CHILDMELODY

Identifier Type: -

Identifier Source: org_study_id