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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT01198912
Eligibility Criteria:
Inclusion Criteria:
* at least 18 years of age, of either sex and any race
* diagnosis of chronic rhinosinusitis with or without nasal polyposis according to the EPOS guidelines research
* Subjects should be regularly scheduled for bilateral functional endonasal endoscopic sinus surgery
* Subjects must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures or compromise his/her safety.
* Subjects must be willing to give informed consent and adhere to visit schedules, medication restrictions, and agree to perform daily diary entries.
* Nonpregnant women of childbearing potential must use a medically acceptable, adequate form of birth control.
Exclusion Criteria:
* Women must not be pregnant, breast feeding, or premenarcheal.
* Subjects who have required oral corticosteroids within the previous four weeks prior to surgery.
* Subjects who have required nasal corticosteroids within the previous one week prior to surgery.
* Subjects with known allergic reaction on tetracyclines, diabetes (type 1 and 2), renal insufficiency, severe liver disease, systemic diseases affecting the nose (e.g. M. Wegener), prior surgeries of the paranasal sinuses.
* Patients with the following diseases should be excluded :
1. Cystic fibrosis based on positive sweat test or DNA alleles
2. Gross immunodeficiency (congenital or acquired)
3. congenital mucociliary problems e.g. primary ciliary dyskinesia (PCD)
4. Non-invasive fungal balls and invasive fungal disease
5. systemic vasculitis and granulomatous diseases
6. Cocaine abuse
7. Neoplasia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01198912
Study Brief:
Protocol Section:
NCT01198912