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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05710276
Other study ID # PI2022_843_0001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 24, 2023
Est. completion date January 2024

Study information

Verified date January 2023
Source Centre Hospitalier Universitaire, Amiens
Contact DJAMAL-DINE DJEDDI, Pr
Phone 03.22.08.76.32
Email djeddi.djamal-dine@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The assessment of digestive inflammation and disease activity in paediatrics Crohn's disease (CD) is currently based on anamnestic, clinical and paraclinical elements such as the paediatric CD activity index (wPCDAI) , faecal calprotectin measuring or digestive endoscopy. Infrared thermal imaging is based on capturing electromagnetic waves, on a specific Wavelength, emitted by the human body surface and representing local thermic-metabolic activity. It concern metabolic activity in digestive inflammations. Infrared imaging is a non-invasive, contactless, stressless technique that assess the variations in skin surface temperature of the patient's entire abdomen or more targeted areas in a single photography. This technique would be useful for determination of Crohn's disease activity, inflammation's degree and partial mapping of inflammatory lesions. In a specific room with a patient lying, the investigators will determine the abdominal infrared radiation with a FLIR® thermal camera. This will be correlated with the measurement of the faecal calprotectin concentration and the composite CD activity index wPCDAI. All measurements will be performed during the standard follow-up of Crohn disease. No additional follow will be necessary.


Recruitment information / eligibility

Status Recruiting
Enrollment 43
Est. completion date January 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group 4 Years to 17 Years
Eligibility Inclusion Criteria: - Patients diagnosed with CD according to the Porto criteria [6] - Aged from 4 years to 17 years-old - Follow-up at the Amiens Picardie University Hospital (CHU Amiens Picardie) - Child's affirmative agreement and assent and permission of their parents to participate in research Exclusion Criteria: - Recent abdominal surgery - Other Inflammatory bowel disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
abdominal infrared radiation
In a specific room (controlled temperature and humidity) with a patient lying on his back, we will determine the abdominal infrared radiation with a FLIR® thermal camera (without contact) and quantify the thermal signal by spectral analysis (in degrees Celsius).

Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary correlation between the quantification of abdominal infrared radiation and faecal calprotectin concentration correlation between the quantification of abdominal infrared radiation determined by the FLIR® thermal camera and quantified by the spectral analysis of the thermal signal (in degrees Celsius) and the determination of faecal calprotectin concentration (µg/g of faeces). This concentration will be determined by ELISA method at Biochemistry in Amiens Picardie Faculty hospital. one year
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