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 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT03906968
Eligibility Criteria:
Inclusion Criteria:
1. Adults ≥18 years of age
2. Complaints of nasal congestion present for 2 weeks or more and a qualifying nasal congestion score of \>5 (10 point VAS scale)
Exclusion Criteria:
1. Fixed structural cause of nasal congestion (moderate or severe septal deviation, moderate or severe nasal valve collapse, Grade 3-4 polyp)
2. Inability to read and understand English
3. Allergic sensitivity to silicone or any other component of device
4. History of severe nose bleeding within last 3 months
5. Anticoagulation (Aspirin is acceptable)
6. Known pregnancy
7. Current nasal crusting or ulceration revealed on rhinoscopy
8. Inability to perform treatment due to underlying medical condition
9. Topical decongestant use in last week
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03906968
Study Brief:
Protocol Section:
NCT03906968