Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 1:21 AM
NCT ID:
NCT04375293
Eligibility Criteria:
Inclusion Criteria:
* Male or Female
* Age: 18-90
* Willingness to participate in the study
* No use of nasal or systemic corticosteroids or immunosuppressants 2 weeks prior to their visit
* Patient groups:
* Control group: absence of any signs of acute or chronic rhinosinusitis
* CRS:
CRSsNP CRSwNP N-ERD: N-ERD as previously confirmed by clinical history or provocation testing
The presence of CRS will be confirmed by endoscopy (part of routine assessment at the ORL department, no study procedure) according to AAO-HNSF guidelines as follows :
• Twelve weeks or longer of two or more of the following signs and symptoms:
* mucopurulent drainage (anterior, posterior, or both)
* nasal obstruction (congestion)
* facial pain-pressure-fullness, or
* decreased sense of smell
AND inflammation is documented by one or more of the following findings:
* purulent (not clear) mucus or edema in the middle meatus or anterior ethmoid region
* polyps in nasal cavity or the middle meatus, and/or
* radiographic imaging showing inflammation of the paranasal sinuses
Exclusion Criteria:
* Children
* Pregnant women (pregnancy test will be performed in women with child bearing potential)
* A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
* Use of nasal or systemic corticosteroids or immunosuppressants 2 weeks prior to their visit
* Patients with cystic fibrosis or immunosuppression.
* Severe anatomic variations or deviations that do not allow access to all areas in the nasal cavity
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04375293
Study Brief:
Protocol Section:
NCT04375293