Covid19NCT04776174
Efficacy and Tolerance of Telerobotic vs Standard Ultrasound Exam in Children
A study testing Ultrasound using the telerobotic Melody system in people with Covid19, run by Centre Hospitalier Intercommunal Creteil at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Covid19
- What is being tested?
- Ultrasound using the telerobotic Melody system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Mar 2021to 3 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient from 1 year to 10 years
- Patient requiring an ultrasound exam (thoracic, abdominal or cardiac)
- French social security affiliation
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHI Créteil
Créteil, 94000
CHI Villeneuve-Saint-Georges
Villeneuve-Saint-Georges
About this study
Official title: Crossover Comparison of the Efficacy and Tolerance of Telerobotic vs Standard Ultrasound Exam in Children
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.
- Conditions
- Covid19
- Being tested
- Ultrasound using the telerobotic Melody system
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound using the telerobotic Melody systemDevice
The children will first have a telerobotic ultrasound abdominal, pulmonary or cardiac followed by a classical ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| standard and telerobotic ultrasound | Experimental | Included patients will have both ultrasound examination: standard ultraosound (abdominal, cardiac or pulmonary depending on the prescription and telerobotic ultrasound Receives: Device: Ultrasound using the telerobotic Melody system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement Between Telerobotic and Conventional Ultrasound Examinations Assessed by Cohen Kappa Coefficient
Agreement between telerobotic and conventional ultrasound examinations was assessed using the Cohen kappa coefficient based on the overall examination conclusions (normal or abnormal) obtained by the two methods. Kappa values range from 0 to 1, where 0 indicates no agreement beyond chance and 1 indicates perfect agreement; higher values indicate better agreement between the two examination methods.
Measured: 1 day
Secondary outcomes (4)
Parent Acceptance of Telerobotic Ultrasound
Parents completed a 5-point Likert questionnaire immediately after the telerobotic ultrasound examination. Responses were reported as the number of participants selecting each response category. Higher levels of agreement indicate greater acceptance.
Measured: Up to 4 hours
Patient Site Assistant Satisfaction
Medical assistant satisfaction questioner for the telerobotic examination using a 5-point Liekert scale from 1: "strongly disagree" to 5: "strongly agree"
Measured: Up to 4 hours
Sonographer Satisfaction
Sonographer satisfaction questioner for the telerobotic examination using a 5-point Liekert scale from 1: "strongly disagree" to 5: "strongly agree"
Measured: Up to 4 hours
Duration of Ultrasound Examination
Duration of the ultrasound examination performed using the telerobotic and conventional ultrasound systems.
Measured: Within 1 day (during the paired standard and telerobotic ultrasound examinations)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Mar 2021
- Primary completion3 Nov 2021
- Study completion3 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- ADECHOTECH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776174
- Sponsor's protocol ID
- CHILDMELODY
- Status last verified
- Nov 2026
- First submitted
- 8 Feb 2021
- Last updated
- 4 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crossover Comparison of the Efficacy and Tolerance of Telerobotic vs Standard Ultrasound Exam in Children
- ClinicalTrials.gov ID
- NCT04776174
- Acronym / sponsor ID
- CHILDMELODY
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- ADECHOTECH
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Posted 4 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| standard and telerobotic ultrasound | Experimental | Device: Ultrasound using the telerobotic Melody systemIncluded patients will have both ultrasound examination: standard ultraosound (abdominal, cardiac or pulmonary depending on the prescription and telerobotic ultrasound |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patient from 1 year to 10 years
- Patient requiring an ultrasound exam (thoracic, abdominal or cardiac)
- French social security affiliation
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound using the telerobotic Melody systemThe children will first have a telerobotic ultrasound abdominal, pulmonary or cardiac followed by a classical ultrasound. | Device | standard and telerobotic ultrasound |
Primary outcome
Agreement Between Telerobotic and Conventional Ultrasound Examinations Assessed by Cohen Kappa Coefficient
Time frame: 1 day
Agreement between telerobotic and conventional ultrasound examinations was assessed using the Cohen kappa coefficient based on the overall examination conclusions (normal or abnormal) obtained by the two methods. Kappa values range from 0 to 1, where 0 indicates no agreement beyond chance and 1 indicates perfect agreement; higher values indicate better agreement between the two examination methods.
4 secondary outcomes
Parent Acceptance of Telerobotic Ultrasound
Time frame: Up to 4 hours
Patient Site Assistant Satisfaction
Time frame: Up to 4 hours
Sonographer Satisfaction
Time frame: Up to 4 hours
Duration of Ultrasound Examination
Time frame: Within 1 day (during the paired standard and telerobotic ultrasound examinations)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound using the telerobotic Melody system in people with Covid19, run by Centre Hospitalier Intercommunal Creteil at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between Telerobotic and Conventional Ultrasound Examinations Assessed by Cohen Kappa Coefficient (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.