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Efficacy and Tolerance of Telerobotic vs Standard Ultrasound Exam in Children

Crossover Comparison of the Efficacy and Tolerance of Telerobotic vs Standard Ultrasound Exam in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04776174
Enrollment
40
Registered
2021-03-01
Start date
2021-03-01
Completion date
2021-11-03
Last updated
2021-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Brief summary

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.

Interventions

DEVICEUltrasound using the telerobotic Melody system

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

Sponsors

ADECHOTECH
CollaboratorUNKNOWN
Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of normal and abnormal standard and telerobotic ultrasound examinations1 dayNumber of normal and abnormal examination conclusion for telerobotic and conventional ultrasound examinations

Secondary

MeasureTime frameDescription
Age of participantsAt baselineAge of patients with telerobotic ultrasound
Number of anomalies foundUp to 4 hoursConventional and telerobotic ultrasound examinations results
Parent satisfactionUp to 4 hoursParent satisfaction questioner for the telerobotic examination using a 5-point Liekert scale from 1: strongly disagree to 5: strongly agree
Medical assistant satisfactionUp to 4 hoursMedical assistant satisfaction questioner for the telerobotic examination using a 5-point Liekert scale from 1: strongly disagree to 5: strongly agree
Sonographer satisfactionUp to 4 hoursSonographer satisfaction questioner for the telerobotic examination using a 5-point Liekert scale from 1: strongly disagree to 5: strongly agree

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026