Chronic Eustachian Salpingitis
Conditions
Keywords
Eustachian tube dysfunction
Brief summary
The objective of this study is to demonstrate that balloon dilation of the Eustachian tubes can be done successfully for treatment of chronic dilatory Eustachian tube dysfunction under local anesthesia with acceptable patient discomfort levels.
Detailed description
This study is a prospective, non-significant risk, multi-center trial of patients with Eustachian tube dysfunction who are refractory to medical management. Patients will undergo balloon dilation of the Eustachian tubes in the office under local anesthesia. We will assess assess the peri-procedural and post-procedure pain levels, and determine the proportion of subjects experiencing normalization of tympanometry and improvement in quality of of life at 6 weeks, 12 weeks, and 52 weeks post-treatment.
Interventions
DEVICEBalloon dilation of the Eustachian tubes
Use the Aera Balloon through the nose to dilate the Eustachian tubes
Sponsors
Acclarent
Piedmont Ear, Nose, Throat and Related Allergy, PC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective, non-significant risk, multi-center, non-controlled trial
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adult male or female aged 22 years and older 2. Persistent ETD as defined by patient-reported symptoms of ETD (including pressure and/or pain and/or clogged and/or muffled sensation in the affected ear(s)) for no less than 12 weeks prior to enrollment, and at least one of the following confirmatory indicators of persistent ETD no less than 12 weeks prior to enrollment B1: Confirmation from referring physician that the subject has experienced persistent ETD symptoms (including pressure and/or pain and/or clogged and or muffled sensation in the affected ear(s)) during an office visit no less than 12 weeks prior to enrollment. Persistent symptoms must be confirmed as not waxing and waning. OR B2: Documented evidence in the ENT physician records that the subject has experienced persistent ETD symptoms (including pressure and/or pain and/or clogged and/or muffled sensation in the affected ear(s)) during an office visit no less than 12 weeks prior to enrollment. Persistent symptoms must be confirmed as not waxing and waning. OR B3: Type B or Type C tympanogram in at least one ear no less than 12 weeks prior to enrollment. OR B4: Otoscopic exam demonstrating TM retraction and/or middle ear fluid no less than 12 weeks prior to enrollment. 3. Failure of appropriate medical management consisting of either a minimum of 4 weeks of continuous daily usage of any intranasal steroid spray (INS) or a minimum of one completed course of an oral steroid, per the investigator's choice. The failed medical management may occur any time within 90 days prior to study enrollment. 4. A positive diagnosis of persistent (i.e. not waxing and waning) ETD, as confirmed with both of the following: D1: Abnormal tympanometry (defined as either Type B or Type C) after failed medical management and within 14 days of study enrollment D2: Symptomatic dysfunction as documented by a Eustachian Tube Dysfunction Questionnaire (ETDQ-7) mean item score ≥ 2.1 after failed medical management 5. Absence of internal carotid artery (ICA) dehiscence into the ET lumen on both sides as confirmed by a computed tomography (CT scan) including temporal bone - to include paranasal sinuses when clinically appropriate
Exclusion criteria
1. Females who are pregnant or lactating 2. Anatomy that requires an adjunctive surgical procedure on the same day as ETBC surgery to allow balloon catheter access to the ET (e.g. septoplasty, polypectomy, turbinate reduction) 3. Concomitant nasal or sinus procedures planned on the same day as ETBC surgery or any time during study participation (e.g. adenoidectomy, sinus surgery) 4. Concomitant ear procedures planned on the same day as ETBC surgery or any time during study participation (e.g. myringotomy, tympanostomy tube placement) 5. History of major surgery of the head or neck within four (4) months prior to enrollment (e.g. adenoidectomy, sinus surgery) 6. History of a patulous ET in either ear 7. History of fluctuating sensorineural hearing loss, in either ear, within the past 5 years, as evidenced by a 20dB change in 3 pure tone average frequencies 8. Active chronic or acute otitis media (AOM), in either ear, as evidenced by bulging TM, erythema, purulent effusion, or cholesteatoma 9. Tympanic membrane perforation or presence of a tympanostomy tube in either ear 10. Tympanosclerosis with opacification of ≥50% of tympanic membrane in either ear 11. Evidence of acute upper respiratory infection 12. Evidence of active Temporomandibular joint disorder (TMJ) per clinical exam (i.e. pain with mouth opening, chewing, clenching; tenderness to palpation deep into the glenoid capsule on wide mouth opening, especially with right and left lateral movements of the jaw; tenderness of the masseter or lateral pterygoid muscles on bimanual intra/extraoral examination) 13. Cleft palate or history of cleft palate repair 14. Craniofacial syndrome, including Down's Syndrome 15. Cystic fibrosis 16. Ciliary dysmotility syndrome 17. Other systemic mucosal diseases or immunodeficiency disorders (e.g. Samters triad, Sarcoidosis, Wegener's granulomatosis), including patients actively taking immunosuppressive drugs 18. Intolerance of protocol-defined medication regimen 19. Prior surgical intervention on Eustachian tube including balloon dilation, laser or mechanical tuboplasty 20. Absence of dilatory muscular contractions (tensor veli palatini or levator veli palatini failure, severe dysfunction) as assessed by endoscopic observation of swallows and yawns 21. Treatment is planned for one ear, but the opposite ear has normal (Type A) tympanogram and the subject complains of ETD symptoms in that ear 22. Treatment is planned for one ear, but the opposite ear has abnormal (Type B or C) tympanogram and the subject has no complaints of ETD symptoms in that ear (asymptomatic)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Pain Assessment Scale to describe procedural pain | during procedure | Assess peri-procedural pain levels with a visual pain assessment scale. The scale has numbering from 0-10 with associated visual pictures that correspond to the degree of pain. Participants will number their pain level and describe the location of pain (ear, nose, forehead, jaw, teeth). |
| Visual Pain Assessment Scale to describe postoperative pain | 2 weeks after procedure | Assess post-procedural pain levels with a visual pain assessment scale. The scale has numbering from 0-10 with associated visual pictures that correspond to the degree of pain. Participants will number their pain level and describe the location of pain (ear, nose, forehead, jaw, teeth). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tympanometry - an objective measure of the negative pressure in the middle ear | 6 weeks after procedure | proportion of subjects experiencing normalization of tympanometry post-treatment, indicating improvement or resolution in the negative pressure in the middle ear. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life assessment using the ETDQ-7 questionnaire | 6 weeks after procedure | Determine the proportion of subjects achieving improvement of 0.5 points at 6 weeks post-treatment, indicating significant improvement in the quality of life with respect to symptoms of Eustachian tube dysfunction. |
Contacts
Primary ContactStudy Coordinator
Backup ContactPrincipal Investigator
Outcome results
None listed