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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT02900794
Eligibility Criteria:
Inclusion Criteria:
* Study will include subjects age 18 or older with chronic rhinosinusitis as described by the guidelines published in the 2015 Clinical practice guideline (update): adult sinusitis of the American Academy of Otolaryngology - Head \& Neck Surgery (AAO-HNS).
1. Males and females aged 18 or greater
2. Chronic rhinosinusitis as described by the guidelines published in the 2015 Clinical practice guideline (update): adult sinusitis of the American Academy of Otolaryngology - Head \& Neck Surgery (AAO-HNS)
a. \>12 weeks of two or more of the following signs i. mucopurulent drainage (anterior, posterior, or both) ii. nasal obstruction or congestion iii. facial pain/pressure or fullness, or iv. decreased ability to smell b. AND inflammation is documented by one or more of the following findings i. Purulent mucus or edema in the middle meatus or ethmoid region ii. Radiographic imaging showing inflammation of the paranasal sinuses
3. At least one episode of CRS documented in study investigator's practice with an endoscopic examination with purulent drainage and edema at the time consistent with CRS
4. Radiographic evidence of sinus inflammation during chronic bacterial rhinosinusitis indicating sinus disease at the ostiomeatal complex.
5. Willing and able to read and sign informed consent form and remain compliant with the protocol and study procedures
6. Able to read and understand English
7. Patients whom are planning to have functional endoscopic sinus surgery.
Exclusion Criteria:
* 1\. Diagnosis of Acute Rhinosinusitis or recurrent acute rhinosinusitis
1. per guidelines published in the 2015 Clinical practice guideline (update): adult sinusitis of the American Academy of Otolaryngology - Head \& Neck Surgery (AAO-HNS)
2\. Polyps in nasal cavity or the middle meatus
3\. Prior sinus surgery, not including rhinoplasty or septoplasty
4\. Physician determined need for ethmoidectomy, polypectomy, septoplasty
5\. Patients with known immunodeficiency, ciliary dysfunction, uncontrolled diabetes (defined as most recent HgA1C \> 5.7), and/or autoimmune disease
6\. Any clinically significant illness that may interfere with the evaluation of the study
7\. Patients who were involved in other clinical studies 6 months prior to the study initiation
8\. Patients unable to adhere to follow-up schedule or protocol requirements
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02900794
Study Brief:
Protocol Section:
NCT02900794