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临床试验/NCT05710276
NCT05710276已完成不适用

Assessment of Intestinal Inflammation by Infrared Thermography in Pediatric Crohn Disease

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2023年6月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
2
主要终点
correlation between the quantification of abdominal infrared radiation and faecal calprotectin concentration

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
Single (Participant)

入排标准

年龄范围
4 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Recent abdominal surgery
  • Other Inflammatory bowel disease

结局指标

主要结局

correlation between the quantification of abdominal infrared radiation and faecal calprotectin concentration

时间窗: one year

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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