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 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT03197558
Eligibility Criteria:
Inclusion Criteria:
1. Adults at least 18 years of age at time of consent
2. Indication for tympanostomy tube insertion per Clinical Practice Guideline,or indicated for tympanostomy tube insertion due to barotrauma or Eustachian tube dysfunction per AAO-HNS Clinical Indicators.
3. Subject is able and willing to comply with the protocol and attend all study visits.
4. Subject is able and willing to provide informed consent.
5. Subject is able to read and understand English.
Exclusion Criteria by Ear:
1. Significantly atrophic, retracted or retraction pocket at location of tube placement, bimeric, monomeric or atelectatic tympanic membrane.
2. Perforated tympanic membrane.
3. Otitis externa.
4. Hemotympanum.
5. Damaged/denuded skin in the auditory canal.
6. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane potentially causing abrasion or irritation to the external ear canal.
7. Notable ear discomfort experienced during audiologic or otoscopic examination.
8. Anatomy that precludes sufficient visualization of and access to the tympanic membrane.
9. Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane.
General Exclusion Criteria
10. Pregnant or lactating females
11. History of sensitivity or allergic reaction to lidocaine HCl, tetracaine, epinephrine, or any hypersensitivity to local anesthetics.
12. Familial history of insensitivity to lidocaine or other local anesthetics of the amide type.
13. Electrically sensitive medical support systems (eg, pacemakers, defibrillators, cochlear implants)
14. Other conditions that would preclude performing the study procedure including iontophoresis system ear plug incompatibility.
15. Health conditions that, in the opinion of the investigator, would present undue risk to the subject, based on device/anesthetic drug product label warnings and precautions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03197558
Study Brief:
Protocol Section:
NCT03197558