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 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
NCT ID:
NCT02087150
Eligibility Criteria:
Inclusion Criteria:
* Adult male or female aged 22 years and older
* Persistent Eustachian tube dysfunction
* Failure of medical management
* Positive diagnosis of ETD
* Absence of internal carotid artery (ICA) dehiscence
* Able to read and understand English
Exclusion Criteria:
* Females who are pregnant or lactating
* Anatomy that requires an adjunctive surgical procedure
* Concomitant nasal or sinus procedures planned on the same day as surgical procedure
* Concomitant ear procedures planned on the same day as surgical procedure
* History of major surgery of the head or neck within four (4) months prior to surgery
* History of patulous ET
* History of fluctuating sensorineural hearing loss
* Active acute otitis media
* Tympanic membrane perforation
* Tympanosclerosis
* Acute upper respiratory infection
* Temporomandibular joint disorder
* Cleft palate
* Craniofacial syndrome
* Cystic fibrosis
* Ciliary dysmotility syndrome
* Systemic mucosal or immunodeficiency disease
* Intolerance of medication for ETD
* Prior intervention of Eustachian tube
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT02087150
Study Brief:
Protocol Section:
NCT02087150