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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT00791934
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects age 17 years or older
* Radiographic evidence of ethmoid disease (baseline CT scan obtained within 30 days of scheduled surgery)
* Diagnosis of chronic sinusitis and failed medical management (minimum of 3 weeks of antibiotics)
Exclusion Criteria:
* Age \< 17 years old
* History of glaucoma or diagnosis of glaucoma (baseline visual exam indicating IOP \>21 mmHg)
* Adequate anatomical distances for treatment
* Patient received oral steroid treatment within two weeks prior to day of surgery
* Radiographic evidence of extensive sinonasal osteoneogenesis which could prevent device placement
* Sinonasal tumors or obstructive lesions
* History of facial trauma that distorts sinus anatomy and precludes access to the ethmoid sinus
* Contracted/underdeveloped ethmoid sinus
* Dehiscent lamina orbitalis
* Previous ethmoid surgery
* Ethmoid mucocele
* Extensive Nasal Polyps
* Asthmatic patients with aspirin sensitivity
* Pregnant or lactating females
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
17 Years
Study:
NCT00791934
Study Brief:
Protocol Section:
NCT00791934