Electronic Nose and Fetal Chromosomal Disorders

Detecting Abnormal Fetal Karyotype by the Electronic Nose Clinical Trial

Official title:

Examining the Ability of Electronic Nose in Detecting Fetal Chromosomal Disorders

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02579213
• Other study ID #: 0200-15-RMB
• Status: Not yet recruiting
• Phase: N/A
• First received: September 3, 2015
• Last updated: October 16, 2015
• Start date: October 2015
• Est. completion date: August 2017

Study information

• Verified date: September 2015
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chromosome Aberrations
• Chromosome Disorders
• Detecting Abnormal Fetal Karyotype by the Electronic Nose

Intervention

Other:
• observational study done only in women candidate for amniocentesis
As a part of routine test in women with obstetrical indication for amniocentesis, we take 30 cc of amniotic fluid. only additional 3 ml of the amniotic fluid are needed for examination by electronic sensors.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examining the ability of the electronic nose in detecting abnormal fetal karyotype	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.	3 years	No