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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT05998356
Eligibility Criteria:
Inclusion Criteria:
* Aged between 18 and 85 years
* Clinical symptoms of OETD with Eustachian tubal score less or equal to 7/14
* Failure of well conducted medical treatment (GERD, allergy, rhinosinusitis) including pressure equalization device used for 1 month or more
* ASA score 1 or 2 (ASA : American Society of Anesthesiologists)
Exclusion Criteria:
* Palatal cleft
* Anatomical anomaly of pharyngeal Eustachian tube ostium on the treated side
* Medical history of nasopharyngeal radiotherapy
* Medical history of middle ear surgery (except myringotomy and/or tympanostomy tube)
* Eardrum perforation in the treated side
* Contraindication of general anesthesia, or major risk of general anesthesia including ASA scores of 3 and 4
* Major nasal obstruction ipsilateral to the Eustachian tube to treat
* Medical history of previous Eustachian Tube Dilation
* Pregnant or nursing woman, or in childbearing age and not willing to use contraception
* Inclusion in another interventional clinical trial
* Protected and vulnerable adult
* Not covered by Health insurance
* Refusal to sign informed consent form
* Subjects unable to attend all scheduled visits or to comply with all trial procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05998356
Study Brief:
Protocol Section:
NCT05998356