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CompletedNCT03379701Updated Dec 20, 2017

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

An observational study in CRS, sponsored by Hillel Yaffe Medical Center. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-20.

Sponsored by Hillel Yaffe Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
71
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • CRS

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Keywords

  • chronic rhinosinusitis, nasal polyposis
03

In context

Nasal Polyps

236 studies on the registry are indexed under Nasal Polyps; 68 are open to participants now.

This study's enrollment of 71 is below the median of 100 across 47 observational studies indexed under Nasal Polyps.

Browse Nasal Polyps studies →

Lead sponsor

Hillel Yaffe Medical Center is the lead sponsor of 305 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  1. Patients age 18 or less, pregnant women
  2. Presence of , hepatitis or any other potentially severe and infectious disease. Patient that had sinus surgery.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
71 participants (actual)
Target follow-up
3 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

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

    SNOT 22 score (score 0-110)

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

  2. 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)

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2014 to primary completion in Sep 2016, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 22, 2017
First posted
Dec 20, 2017
StartActual
Sep 28, 2014
Primary completionActual
Sep 27, 2016
CompletionActual
Sep 27, 2016
Last update
Dec 20, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03379701
Collaborators
The Technion
Responsible party
Sponsor
First posted
Dec 20, 2017
Start date
Sep 28, 2014
Primary completion
Sep 27, 2016
Completion
Sep 27, 2016
Last update
Dec 20, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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