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

Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03379701
Collaborator
The Technion (Other)
71
Enrollment
24
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    71 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Applications of Nanotechnology and Chemical Sensors for the Detection and Identification of Chronic Sinusitis Subtypes by Respiratory Samples
    Actual Study Start Date :
    Sep 28, 2014
    Actual Primary Completion Date :
    Sep 27, 2016
    Actual Study Completion Date :
    Sep 27, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    CRSwPolyps with no Eosonophilia

    CRS patients with nasal polyposis, and no eosonophilia.
    CRSwPolyps with Eosonopholia

    CRS patients with nasal polyposis and eosonophilia.
    CRS without Polyps

    Patients with chronic rhinosinusitis and no nasalpolyposis.
    PCD

    Patients with Primrary ciliary dyskinesia .
    AFRS

    Patients with allergic fungal rhinosinusitis.
    allergic rhinitis

    Patients with allergic rhinitis
    Control

    Healthy subjects.

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. CRS patients that presented in the Rhinologic clinic at the Hillel Yaffe Medical Center. CRS patients that never had FESS - endoscopic sinus surgery.

    2. Willing and able to give inform consent

    Control subjects:

    1. 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.

    2. Willing and able to give informed consent

    Exclusion Criteria:

    1. Patients age 18 or less, pregnant women

    2. Presence of HIV, hepatitis or any other potentially severe and infectious disease. Patient that had sinus surgery.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hillel Yaffe Medical Center
    • The Technion

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hillel Yaffe Medical Center
    ClinicalTrials.gov Identifier:
    NCT03379701
    Other Study ID Numbers:
    • 0037-14
    First Posted:
    Dec 20, 2017
    Last Update Posted:
    Dec 20, 2017
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hillel Yaffe Medical Center
    chronic rhinosinusitis, nasal polyposis
    Additional relevant MeSH terms:
    Sinusitis

    Study Results

    No Results Posted as of Dec 20, 2017