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Completed

NCT Number: NCT03379701

Applications of Nanotechnology and Chemical Sensors for the Detection and Identification of Chronic Sinusitis Subtypes by Respiratory Samples

Professor Hossam Haick from the Technion, developed an electronic nose for diagnosis of diseases via breath samples.

Biomarkers from nose and sinuses and upper respiratory tract can be detected by "electronic nose".

Identification of biomarkers from nose and sinuses and upper respiratory tract can differentiate between the subtypes of CRS (Chronic rhinosinusitis) and may serve as markers for disease (vs controls), of disease activity (predicting aggressive disease course, predicting Malignant vs Benign nasal "polyps", as inverted papillpma or carcinoma; predicting response to therapy (Steroid , Antibiotics, Nasal wash, Surgery).

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Key information

About this study

Professor Hossam Haick from the Technion, developed an electronic nose for diagnosis of diseases via breath samples.

Biomarkers from nose and sinuses and upper respiratory tract can be detected by "electronic nose".

Identification of biomarkers from nose and sinuses and upper respiratory tract can differentiate between the subtypes of CRS (Chronic rhinosinusitis) and may serve as markers for disease (vs controls), of disease activity (predicting aggressive disease course, predicting Malignant vs Benign nasal "polyps", as inverted papillpma or carcinoma; predicting response to therapy (Steroid , Antibiotics, Nasal wash, Surgery).

The aim of this study is to evaluate various CRS diseases with the Electronic Nose trying to better differentiate CRSwPolyps , CRS without Polyps, PCD, AFS, Vasculitis (as Wegener Granulomatosis) and Allergic Rhinitis with CRS.

For that reason samples were taken from patients from different groups of "CRS patients": 1. CRSwPolyps with no Eosonophilia , 2. CRSwPolyps with Eosonopholia, 3. CRS without Polyps, 4. PCD, 5. AFS, 6. allergic rhinitis and 7. Control subjects.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CRS patients that presented in the Rhinologic clinic at the Hillel Yaffe Medical Center. CRS patients that never had FESS - endoscopic sinus surgery.
  • Willing and able to give inform consent

Control subjects:

  • Age and gender match control individuals that do not have CRS or any other condition that is defined as nasal disease. These individuals will be recruited as "Healthy Population Reference" group.
  • Willing and able to give informed consent

Exclusion criteria

  • Patients age 18 or less, pregnant women
  • Presence of HIV, hepatitis or any other potentially severe and infectious disease. Patient that had sinus surgery.

Treatment and study plan

Primary outcomes

  1. discrimination between healthy and CRS subtypes based on SNOT 22 questionnaire results

    Time frame: change in score from recruitment and every six month until 3 years after recruitment.

    SNOT 22 score (score 0-110)

  2. Successful discrimination between healthy and CRS subtypes based on sensor response (electrical resistance measurements)

    Time frame: Change of electrical resistance from recruitment and every six month until 3 years after recruitment.

    Electrical resistance-Disease diagnosis based on breath analysis data classification using an artificial olfactory system (AKA, Electronic nose)

Sponsors and collaborators

Lead sponsor

Hillel Yaffe Medical Center

Other Gov

Collaborators

  • The Technion

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 20, 2017
Registry last updated
Dec 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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