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New device could make measuring heart health in kids easier

NCT ID NCT02991703

Diagnosis Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This study tests whether a simpler device called pOpmètre can accurately measure arterial stiffness in children aged 4 to 8. Arterial stiffness is an important sign of heart and blood vessel health. The standard device, Sphygmocor, is harder to use in children. If pOpmètre works well, it could make checking artery health easier and less stressful for kids.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could provide a simpler, less invasive way to measure arterial stiffness in children, helping detect cardiovascular risk earlier.
What could go wrong
This is a small validation study in 60 children, so results may not apply to all children or settings. The device may not be as accurate as the standard method.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Dec 2016

Finished

Jul 2017

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 8 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * children between 4 and 8 years old hospitalized in the Mother and Children Hospital in Nantes during the study period. Exclusion Criteria: * Vasoconstrictor treatment, * compressive bandage on the measured area, * peripheral venous access on the measured side, * vascular surgery or pathology on the measured area, * significant pain or agitation, * parental or legal representative disapproval, * child disapproval.

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Conditions

The condition(s) this trial relates to.

arteriosclerosis disorder atherosclerosis cardiovascular disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arteriosclerosis Atherosclerosis Cardiovascular diseases

Contacts and locations

Locations

  • CHU de Nantes

    Nantes, 44093, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.