NCT06666140Not yet recruiting
Preliminary Study of Pediatric Diaphragmatic Elastography
Ultrasound Functional Analysis of the Diaphragm and Upper Digestive Tract in Patients with Congenital Diaphragmatic Hernia
Source: ClinicalTrials.gov · Last updated 30 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 28 Oct 2024
- Start date
- 15 Nov 2024
- Primary completion date
- 15 Nov 2027
- Lead sponsor
- University Hospital, Strasbourg, France
- NCT number
- NCT06666140
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 15 Nov 2024 to the primary completion date, 15 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 treated with muscle relaxant
Other illness
- History of surgery of the upper digestive tract (esophagus and/or gastric and/or duodenal)
Other
- Patient without thoracic pathology
- Refusal
- Language barrier
- Diaphragmatic pathology
- Any myopathy
- Patient on muscle relaxant
- Patient with a viral picture in progress at the time of examination (assessment by the investigator)
- 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
Who the study is looking for
- 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
Age in the registry: 3 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopitaux Universitaires de Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.