RecruitingNAINTERVENTIONAL

"Clinical Ultrasound, a New Link Between Town and Hospital in Seine-Saint-Denis". (ECHO93)

The ECHO93 study is exploring how a new, easy-to-use ultrasound device, called echOpen, can improve patient care in Seine-Saint-Denis, France. It's designed to see if using this portable device can help doctors make diagnoses faster. The study is divided into three parts. First, it will be used in a hospital's rapid diagnosis unit. Next, it will be introduced to local GP practices and emergency departments that refer patients to the hospital. Finally, it will be tested in a health bus that travels to different communities. The main goal is to understand if echOpen can lead to quicker diagnoses, reduce the need for many extra tests, and make it easier for patients to get the right care, whether at the hospital or closer to home.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

100

Start

12 Feb 2025

Estimated completion

30 Sep 2026

Diagnosis Clinical Ultrasound

What is this study about?

The ECHO93 study, which stands for "Clinical Ultrasound, a New Link Between Town and Hospital in Seine-Saint-Denis," is looking into a new way to help doctors diagnose patients. It's focused on a small, portable ultrasound device called echOpen. Ultrasound uses sound waves to create pictures of the inside of your body, much like a baby scan. The main idea behind this study is to see if using this easy-to-handle device can help doctors figure out what's wrong with patients more quickly.

The study will happen in three stages. In the first stage, doctors in a special rapid diagnosis unit at the Jean Verdier Hospital will learn to use the echOpen device. They'll then use it with patients to see if it makes diagnoses faster and helps them avoid needing lots of other tests. The second stage expands this to local doctors' surgeries and the hospital's emergency department, looking at how it helps patients get referred for a diagnosis.

Finally, the third stage will take the echOpen device on a Health Bus that visits different communities. This part of the study will check if the device can help decide whether someone needs to go to an emergency service or if their condition can be managed right on the bus. All these steps are about improving how quickly and efficiently patients get the care they need, bringing hospital-level technology closer to where people live.

Key takeaways

The study explores a portable ultrasound device (echOpen) for faster diagnoses.
It aims to reduce the time patients wait for a diagnosis.
Participation involves having an ultrasound as part of your regular care.
Ultrasound is generally a very safe procedure.
The study hopes to reduce the need for other, more complex tests.
You can stop participating at any time without affecting your healthcare.

Who may be eligible?

To take part in this study, you must be an adult aged 18 or over and agree to participate by signing a consent form. You would be considered if you are being cared for at certain locations involved in the study.

These locations include the rapid diagnosis unit or emergency department at Jean Verdier Hospital, or specific local doctor's practices in Pantin or Aulnay-sous-Bois, if you are being referred for a quick diagnosis. If you are seen by the Health Bus that travels to different areas, you might also be eligible during the third phase of the study.

However, you cannot take part if you are being treated for anaemia caused by a lack of iron. Also, if you are unable to speak French and don't have someone who can translate for you, you cannot join. People who are very unwell and need immediate, life-saving care, or those with a very high body mass index (over 34.9 kg/m2), are also unable to participate. Finally, if you are in police custody or otherwise deprived of your freedom by a court order, you cannot be included.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you able to provide your written consent to participate?
Are you being seen at specific locations like the Jean Verdier Hospital, MSP Pantin, or Dr. Taybaly's practice, or the Health Bus for a diagnosis?
Are you able to speak French, or is there a translator available for you?
Are you not currently being treated for iron-deficiency anaemia?
Are you generally stable and not in a life-threatening medical emergency?

Answer every question to see your result.

What does participation involve?

If you take part in this study, doctors will use the echOpen device, a portable ultrasound, as part of your usual medical assessment. This is not a treatment, but a diagnostic tool. You will simply have the ultrasound examination as requested by your doctor. The study is observing how this new device affects the speed of diagnosis and the number of other tests you might need. There are no extra visits specifically for the study; it happens during your regular appointments. The total duration of your participation would depend on your individual healthcare journey.

Potential risks and benefits

The main benefit of this study could be a quicker diagnosis for your condition, which might reduce anxiety and allow for faster treatment if needed. It might also mean fewer additional tests like MRI scans or CT scans. The echOpen device uses ultrasound, which is generally considered very safe and does not involve radiation. There are no known direct risks to you from using the echOpen probe itself. You are always free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Unite de Diagnostic Rapide - Medecine Interne Hopital Jean Verdier
Verified postcode
Bondy, France· Recruiting

Common questions

What is echOpen?

EchOpen is a new, portable ultrasound device used by doctors to create pictures of the inside of your body, helping them understand what's causing your symptoms.

Will this study change my treatment?

No, the study is about how doctors *diagnose* conditions more efficiently, not about your specific treatment. Your treatment will be decided by your doctor as usual.

Is ultrasound safe?

Yes, ultrasound uses sound waves and is generally considered very safe. It doesn't involve X-rays or radiation and is commonly used for many medical purposes, including checking on babies during pregnancy.

Do I have to do anything extra if I join the study?

No, your participation will happen during your normal medical appointments where the echOpen device might be used. It won't require extra visits or special actions from you.

What if I change my mind about participating?

You are free to withdraw from the study at any point without it affecting the medical care you receive.

How to find out more

Anne BOURGARIT, PUPH

anne.bourgarit@aphp.fr 00331 48 02 61 59 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.