Electronic Nose and Fetal Chromosomal Disorders

NCT ID: NCT02579213

Last Updated: 2015-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-08-31

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.

Conditions

Detecting Abnormal Fetal Karyotype by the Electronic Nose

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

women candidates for amniocentesis

pregnant women candidates for amniocentesis between 17-33 gestational weeks

observational study done only in women candidate for amniocentesis

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

0200-15-RMB

Identifier Type: -

Identifier Source: org_study_id