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 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT01990820
Eligibility Criteria:
Inclusion Criteria:
1. Sinonasal symptoms of at least 12 weeks' duration or recurrent sinusitis \>3x/year
2. Failure to respond to 3-week course of antibiotic and 3 month course of nasal steroid preparations or antihistamines as well as saline nasal irrigation
3. Rhinosinusitis documented by CT scan following oral antibiotic course.
Computer tomographic findings considered to be consistent with sinusitis include partial or complete sinus opacification.
Allergy and immunology workup will be recommended on an individual basis -
Exclusion Criteria:
1. Patients with extensive sinonasal polyps, extensive sinonasal osteoneogenesis, sinonasal tumors
2. History of facial trauma that distorts sinus anatomy
3. Ciliary dysfunction
4. Pregnancy will be excluded.
5. Patients with cystic fibrosis, craniofacial anomalies, metabolic disorders, or immunodeficiencies
6. Patients who have had their adenoids removed and thus may be candidates for functional endoscopic sinus surgery will also be excluded.
7. Patients with a history of sinus surgery or significant anatomic abnormalities on CT scan that would require endoscopic sinus surgery or septoplasty would also be excluded.
Of note, children who will be undergoing concurrent surgeries will not be excluded.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
12 Years
Study:
NCT01990820
Study Brief:
Protocol Section:
NCT01990820