Preliminary Study of Pediatric Diaphragmatic Elastography (NCT06666140) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Preliminary Study of Pediatric Diaphragmatic Elastography
France80 participantsStarted 2024-11-15
Plain-language summary
This diaphragmatic elastography study is a preliminary pilot study to have first values of diaphragmatic stiffness in patients with a history of diaphragmatic hernia and to estimate the difference in stiffness compared to a group of patients without a history of hernia.
The hypothesis is to be able to correlate the values found with the patients' symptomatology and thus to better monitor patients by a simple, accessible, painless and reproducible diagnostic tool, to better understand their evolution and even to be able to anticipate possible difficulties (reflux, respiratory disorders, scoliosis, etc.).
Ultrasound elastography is a recent and clinically recognized method that uses an ultrasound approach to determine tissue stiffness in a non-invasive way.
Who can participate
Age range
3 Years – 17 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:
* Group HDC:
* Patient followed at the CCMR (centres de compétence maladies rares) HDC of the Strasbourg University Hospital
* Aged between 3 and 17 years old inclusive
* Indifferent Sex
* Subject affiliated to a social protection health insurance scheme or beneficiary of such a scheme
* Subject able to understand the objectives and risks of the research and to provide dated and signed informed consent
* Subject who has been informed of the results of the preliminary medical examination
Control group:
* Subject followed in pediatric surgery
* Aged between 3 and 17 years old inclusive
* Indifferent Sex
* Subject affiliated to a social protection health insurance scheme or beneficiary of such a scheme
* Subject able to understand the objectives and risks of the research and to provide dated and signed informed consent
* Subject who has been informed of the results of the preliminary medical examination
Exclusion Criteria:
* Group HDC:
* Refusal
* Language barrier
* Diaphragmatic surgery within the last 3 months
* Patient with a viral picture in progress at the time of examination (assessment by the investigator)
* Patient treated with muscle relaxant
* Inability to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.)
* Subject under safeguard of justice
* Subject under guardianship or curatorship
* Pregnant or breastfeeding woman
Control group:
* Patient without t…
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.
What they're measuring
1
To estimate the difference in diaphragm stiffness between a group of children with a diaphragmatic hernia with or without a prosthesis and a group of children without any diaphragmatic pathology.