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:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT04970966
Eligibility Criteria:
Inclusion Criteria:
* Patient is 18 years of age or older
* Patient has a clinical indication for and has consented for primary or revision bilateral ESS and had evidence of ethmoid disease bilaterally (Lund-Mackay score at least 1 on each side).
* Diagnosed with CRS based on American Academy of Otolaryngology - Head and Neck Surgery guidelines
Exclusion Criteria:
* Patient has a known history of immune deficiency such as immunoglobulin G or A subclass deficiency, or Human Immunodeficiency Virus (HIV).
* Patient has concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease (e.g. cancer, HIV, etc.)
* Patient has clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90 day followup period.
* Patient is currently participating in another clinical trial.
* Patient has a known coagulation disorder.
* Patient is allergic to shellfish.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04970966
Study Brief:
Protocol Section:
NCT04970966