Electronic Nose and Fetal Chromosomal Disorders

• Conditions: Detecting Abnormal Fetal Karyotype by the Electronic Nose
• Interventions: Other: observational study done only in women candidate for amniocentesis

• Registration Number: NCT02579213
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Status Verified: 2015-09
• Study First Submitted: 2015-09-03
• Study Start: 2015-10
• Study First Submitted QC: 2015-10-16
• Last Update Submitted: 2015-10-16
• Study First Posted: 2015-10-19
• Last Update Posted: 2015-10-19
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
women candidates for amniocentesis	observational study done only in women candidate for amniocentesis	pregnant women candidates for amniocentesis between 17-33 gestational weeks

Primary Outcome Measures

Name	Time	Method
Examining the ability of the electronic nose in detecting abnormal fetal karyotype	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.