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 @ 2:47 PM
Ignite Modification Date:
2025-12-24 @ 2:47 PM
NCT ID:
NCT02600559
Eligibility Criteria:
Inclusion Criteria includes, but is not limited to:
* Subject is a male or female aged 6 months to 17 years, inclusive
* Subject has a history of otitis media requiring bilateral tympanostomy tube placement
* Subject's caregiver is willing to comply with the protocol and attend all study visits
Exclusion Criteria includes, but is not limited to:
* Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with TT placement
* Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, except adenoidectomy, airway endoscopy, nasal endoscopy, and nasal cautery for epistaxis
* Subject has a history of sensorineural hearing loss
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
17 Years
Study:
NCT02600559
Study Brief:
Protocol Section:
NCT02600559