Clinical Trial: Electronic Nose and Fetal Chromosomal Disorders
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational
Official Title: Examining the Ability of Electronic Nose in Detecting Fetal Chromosomal Disorders
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 Summary:
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.
Sponsor: Rambam Health Care Campus
Current Primary Outcome: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Rambam Health Care Campus
Dates:
Date Received: September 3, 2015
Date Started: October 2015
Date Completion: August 2017
Last Updated: October 16, 2015
Last Verified: September 2015
