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

CRS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379701
• Other study ID #: 0037-14
• Status: Completed
• Phase: N/A
• First received: November 22, 2017
• Last updated: December 19, 2017
• Start date: September 28, 2014
• Est. completion date: September 27, 2016

Study information

• Verified date: December 2017
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: September 27, 2016
• Est. primary completion date: September 27, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CRS
• Sinusitis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center	The Technion

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.