Status:
NOT_YET_RECRUITING
Long-term Assessment of Balloon Eustachian Tuboplasty for Obstructive Eustachian Tube Disease
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Eustachian Tube Dysfunction
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
To date, more than 130 000 Balloon Eustachian Tuboplasty (BET) procedures have been performed worldwide. This procedure is proposed in case of Obstructive Eustachian Tube Dysfunction (OETD) with or wi...
Detailed Description
Obstructive Eustachian Tube Dysfunction (OETD) is a common medical condition whose prevalence is estimated to be 4.6% in the general population. Subjects suffering from OETD display various symptoms s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT05998356
Start Date
October 1 2023
End Date
January 1 2027
Last Update
September 21 2023
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