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 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT01346332
Eligibility Criteria:
Inclusion Criteria:
* At least 2 years old
Exclusion Criteria:
* Pregnant or lactating females
* Subject with a history of sensitivity or reaction to lidocaine, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution
* Significant atrophic or perforated tympanic membrane
* Otitis externa
* Damaged or denuded skin in the auditory canal
* Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
* Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
* Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT01346332
Study Brief:
Protocol Section:
NCT01346332