跳至主要内容
临床试验/NCT02622139
NCT02622139已完成不适用

Monocentric, Prospective Interventional Study to Assess the Degree of Disease Activity With a Multispectral Optoacoustic Tomography (MSOT) Handheld Scanner in Patients With Crohn's Disease or Ulcerative Colitis

University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 344 人开始时间: 2015年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
344
试验地点
1
主要终点
Correlation of MSOT-data with sonographic parameters

研究概览

简要总结

Monocentric, prospective interventional study to assess the degree of disease activity with a multispectral optoacoustic tomography (MSOT) handheld scanner in patients with Crohn's disease or ulcerative colitis.

详细描述

The proposed study is designed as a pilot study to evaluate the usefulness of MSOT for the evaluation of disease activity in IBD patients. As current methods for the evaluation of intestinal inflammation in IBD have relevant restrictions, new, non-invasive, quantitative, and accurate modalities are urgently needed. In comparison to other techniques, MSOT provides relevant advantages such as non-invasive imaging, high spatial resolution (this is of special importance for the evaluation of the intestine, which can be only a few millimeters thick), and highly sensitive detection of specific molecules such as total hemoglobin or oxy- /deoxygenated hemoglobin. These advantages suggest MSOT as an outstanding technique for evaluating disease activity in IBD.

The proposed study incorporates nearly no risk for participating patients and might provide relevant data for more a more in depth analysis of MSOT for IBD diagnosis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Histological verified Crohn's disease or ulcerative colitis
  • •Age > 18 years

排除标准

  • •Age < 18 years
  • •Mental retardation of the patient with restriction of general judgment and awareness

研究组 & 干预措施

Multispectral Optoacoustic Tomography

Experimental

Multispectral Optoacoustic Tomography (MSOT) for the evaluation of disease activity in inflammatory bowel diseases (IBD)

干预措施: Multispectral Optoacoustic Tomography (MSOT) (Device)

结局指标

主要结局

Correlation of MSOT-data with sonographic parameters

时间窗: 12 month

Correlation of MSOT-data with clinical activity scores of IBD

时间窗: 12 month

次要结局

未报告次要终点

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Sponsor

研究点 (1)

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