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 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT05741333
Eligibility Criteria:
Inclusion Criteria:
* Patients aged ≥6 months to \<13 years
* Planned tympanostomy tube insertion
* Patient is able to commit to the follow-up visits and assessments
Exclusion Criteria:
* Anatomy that precludes sufficient visualization of the tympanic membrane
* Anatomy that precludes safe access to the tympanic membrane and safe use of the Solo+ TTD
* Narrow ear canals
* Congenital or craniofacial abnormalities affecting the ear
* No baseline audiometry or tympanometry
* Familial history of insensitivity to anesthetic components
* Patient unable to remain still or is unsuitable for protective stabilization to undergo an in-office procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
13 Years
Study:
NCT05741333
Study Brief:
Protocol Section:
NCT05741333