跳至主要内容
临床试验/NCT02579213
NCT02579213Unknown不适用

Examining the Ability of Electronic Nose in Detecting Fetal Chromosomal Disorders

Rambam Health Care Campus0 个研究点目标入组 500 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
主要终点
Examining the ability of the electronic nose in detecting abnormal fetal karyotype

研究概览

简要总结

"electronic nose"- the tiny sensors, will smell and detect the changes in the sample of abnormal fetal karyotype, and fluid that will be confirmed by amniocentesis.

详细描述

The biochemical engineering department had developed a device called "electronic nose" that can detect various diseases Including cancer and asthma on basis of evaporable substances. The device simulates the human nose ", which includes an array of tiny sensors connected to nanometric sizes electronic calculating unit.. Thanks to their small size, electrical, physical and chemical properties, the sensitive sensors smell and identified changes in composition of the materials that characterize various diseases including kidney disease and asthma.

The electronic nose was developed by Professor Haick from the Technion. The main concept of the device is testing and characterization a trace amounts of substances in the air with the help of nana-technology sensors the idea is revolutionary and would allow the diagnosis of different diseases, like cancer, by exhaling air into the device.

The test is simple and not complicated to perform ,the examiner inhale air into a bag which connected to the "electronic nose". The molecules of the patient's breath will be tied to sensors and transmit an electrical signal to computer chip.

After processing the data the "electronic nose "can distinguish between normal cells and pathological cells.

Hypothesis

the tiny sensors ("electronic nose") will smell and detect the changes in the sample of abnormal fetal karyotype, and fluid that will be confirmed by amniocentesis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
16 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women candidates for amniocentesis
  • 17-33 gestational weeks

排除标准

  • women that refuse to participate in the research
  • women older than 45 or less than 16

结局指标

主要结局

Examining the ability of the electronic nose in detecting abnormal fetal karyotype

时间窗: 3 years

the electronic nose can detect various diseases Including cancer and asthma on basis of evaporable substances. The device simulates the human nose ", which includes an array of tiny sensors connected to nanometric sizes electronic calculating unit. 30 cc of amniotic fluid are part of routine tests and the rest of the amount (3 ml) is intended for research, this sample will be saved in cooling (-20) and subsequently transferred to the Technion, for examination by electronic sensors. The amount of amniotic fluid designed for research is a minimal amount and will not hurt the fetus. At the end of the study following the data processing, we will be able to appreciate the effectiveness of the electronic nose in diagnosing fetal chromosomal disorders.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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