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 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT03347461
Eligibility Criteria:
Inclusion Criteria:
* Children (6 months to 10 years)
* Clinical diagnosis of bilateral middle ear effusion or recurrent acute otitis media requiring tympanostomy tube placement
Exclusion Criteria:
* Patient having any other concurrent surgery
* History of mastoid surgery, chronic or recurrent bacterial infections
* Tympanic membrane perforations
* History of immunodeficiency disease
* Abnormalities of the tympanic membrane or middle ear
* Otic or systemic corticosteroid within 7 days of surgery
* Topical or systemic antimicrobials or antifungal agents prior to their particular washout intervals
* Concurrent use of anti-inflammatory agents
* Allergy to the medications used in this study and their components
* Menarcheal or postmenarcheal female.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
10 Years
Study:
NCT03347461
Study Brief:
Protocol Section:
NCT03347461