跳至主要内容
临床试验/NCT03379701
NCT03379701已完成不适用

Applications of Nanotechnology and Chemical Sensors for the Detection and Identification of Chronic Sinusitis Subtypes by Respiratory Samples

Hillel Yaffe Medical Center0 个研究点目标入组 71 人开始时间: 2014年9月28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
71
主要终点
Successful discrimination between healthy and CRS subtypes based on sensor response (electrical resistance measurements)

研究概览

简要总结

Professor Hossam Haick from the Technion, developed an electronic nose for diagnosis of diseases via breath samples.

Biomarkers from nose and sinuses and upper respiratory tract can be detected by "electronic nose".

Identification of biomarkers from nose and sinuses and upper respiratory tract can differentiate between the subtypes of CRS (Chronic rhinosinusitis) and may serve as markers for disease (vs controls), of disease activity (predicting aggressive disease course, predicting Malignant vs Benign nasal "polyps", as inverted papillpma or carcinoma; predicting response to therapy (Steroid , Antibiotics, Nasal wash, Surgery).

详细描述

Professor Hossam Haick from the Technion, developed an electronic nose for diagnosis of diseases via breath samples.

Biomarkers from nose and sinuses and upper respiratory tract can be detected by "electronic nose".

Identification of biomarkers from nose and sinuses and upper respiratory tract can differentiate between the subtypes of CRS (Chronic rhinosinusitis) and may serve as markers for disease (vs controls), of disease activity (predicting aggressive disease course, predicting Malignant vs Benign nasal "polyps", as inverted papillpma or carcinoma; predicting response to therapy (Steroid , Antibiotics, Nasal wash, Surgery).

The aim of this study is to evaluate various CRS diseases with the Electronic Nose trying to better differentiate CRSwPolyps , CRS without Polyps, PCD, AFS, Vasculitis (as Wegener Granulomatosis) and Allergic Rhinitis with CRS.

For that reason samples were taken from patients from different groups of "CRS patients": 1. CRSwPolyps with no Eosonophilia , 2. CRSwPolyps with Eosonopholia, 3. CRS without Polyps, 4. PCD, 5. AFS, 6. allergic rhinitis and 7. Control subjects.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • CRS patients that presented in the Rhinologic clinic at the Hillel Yaffe Medical Center. CRS patients that never had FESS - endoscopic sinus surgery.
  • Willing and able to give inform consent
  • Control subjects:
  • Age and gender match control individuals that do not have CRS or any other condition that is defined as nasal disease. These individuals will be recruited as "Healthy Population Reference" group.
  • Willing and able to give informed consent

排除标准

  • Patients age 18 or less, pregnant women
  • Presence of HIV, hepatitis or any other potentially severe and infectious disease. Patient that had sinus surgery.

结局指标

主要结局

Successful discrimination between healthy and CRS subtypes based on sensor response (electrical resistance measurements)

时间窗: Change of electrical resistance from recruitment and every six month until 3 years after recruitment.

Electrical resistance-Disease diagnosis based on breath analysis data classification using an artificial olfactory system (AKA, Electronic nose)

discrimination between healthy and CRS subtypes based on SNOT 22 questionnaire results

时间窗: change in score from recruitment and every six month until 3 years after recruitment.

SNOT 22 score (score 0-110)

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

相似试验