Sponsor study identifier
observational
71
0 countries
N/A
Study Start
September 28, 2014
Actual (reported)Primary Completion
September 27, 2016
Actual (reported)Study Completion
September 27, 2016
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 27, 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 28, 2014
Actual (reported)September 27, 2016
Actual (reported)September 27, 2016
Actual (reported)November 22, 2017
Actual (reported)December 20, 2017
Actual (reported)discrimination between healthy and CRS subtypes based on SNOT 22 questionnaire results
SNOT 22 score (score 0-110)
change in score from recruitment and every six month until 3 years after recruitment.
Successful discrimination between healthy and CRS subtypes based on sensor response (electrical resistance measurements)
Electrical resistance-Disease diagnosis based on breath analysis data classification using an artificial olfactory system (AKA, Electronic nose)
Change of electrical resistance from recruitment and every six month until 3 years after recruitment.
CRS patients with nasal polyposis, and no eosonophilia.
CRS patients with nasal polyposis and eosonophilia.
Patients with chronic rhinosinusitis and no nasalpolyposis.
Patients with Primrary ciliary dyskinesia .
Patients with allergic fungal rhinosinusitis.
Patients with allergic rhinitis
Healthy subjects.
CRS patients will be recruited through the Rhinologic clinic at the Hillel Yaffe Medical Center, after signing an informed consent. Healthy individuals that meet the inclusion/ exclusion criterions will be recruited from among the patient's escorts to the clinic or patients coming for other surgeries (unrelated spouse or acquaintance after signing an informed consent.
An overall of 2-4 liter breath samples will be collected in inert Mylar bags and immediately transferred to sorbent tubes.
71 participants (actual enrollment reported by the registry).
First Submitted
November 22, 2017
First Posted
December 20, 2017
Study Start
September 28, 2014
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
September 27, 2016
Actual (reported)Study Completion
September 27, 2016
Actual (reported)Last Updated
December 20, 2017
Record last verified: 2017-12
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Source: ClinicalTrials.gov.
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