Efficacy of the echOpen Device to Detect Pyelocaliceal Dilation and Hepatic Steatosis (NCT05280145) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of the echOpen Device to Detect Pyelocaliceal Dilation and Hepatic Steatosis
France200 participantsStarted 2022-08-21
Plain-language summary
In recent years, portable and ultra-portable ultrasound devices are increasingly used by the non radiologists, notably cardiologists or obstetrician gynecologist, at the patient's bedside to visualize and measure anatomical structures and fluid and provide the clinical examination with additional signs allowing quicker and more confident clinical decisions.
This innovative approach is slowed down by the accessibility of these miniaturized devices, the price of which remains high.
The echOpen device includes an ultra-portable ultrasound probe and a mobile application that allows the image to be displayed on a smartphone via a WIFI protocol.
The objective of the clinical investigation is to show that the echOpen device, using three frequencies 3.5 Mhz, 5.0 Mhz and 7.5 Mhz, allows identifying the semiological signs or anatomical structures of interest located at several depths of the body, with a performance similar to other devices routinely used in clinical departments.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patient (age ≥ 18 years old)
* Patient having signed the informed consent to participate in this clinical investigation
* Patient affiliated to the social security scheme
* Patient arriving in the hospital clinical ward (own initiative or by emergency services) whose clinical symptomatology suggests the presence of pathological elements which would be visible using an ultrasound probe in the following cases:
* Search for pyelocaliceal dilation: patient consulting for abdominal and/or lumbar pain and/or iliac fossa, fever, pain in the right or left iliac fossa, anuresis
* Search for hepatic steatosis: in a case of global clinical examination, abnormal laboratory test results, known or suspected metabolic disease, any situation suggesting the presence of hepatic steatosis
Exclusion Criteria:
* Minor patient (age \< 18 years)
* Patients under the State Medical Assistance (AME)
* Obese patient (body mass index \> 29.9)
* Patient in too serious condition for the clinical examination to be done fully and/or with additional exploratory time
* Unstable patient: need for immediate care, impossibility to carry out a thorough clinical examination including interview, palpation, auscultation, percussion
* Known allergy to ultrasound gel
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.