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Clinical Trials/NCT02579213
NCT02579213
Unknown
Not Applicable

Examining the Ability of Electronic Nose in Detecting Fetal Chromosomal Disorders

Rambam Health Care Campus0 sites500 target enrollmentOctober 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Detecting Abnormal Fetal Karyotype by the Electronic Nose
Sponsor
Rambam Health Care Campus
Enrollment
500
Primary Endpoint
Examining the ability of the electronic nose in detecting abnormal fetal karyotype
Last Updated
10 years ago

Overview

Brief Summary

"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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
August 2017
Last Updated
10 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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.

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