Feasibility of Balloon Dilation of the Eustachian Tubes Under Local Anesthesia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility of Balloon Dilation of the Eustachian Tubes for Dilatory Dysfunction Under Local Anesthesia

Conditions
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Chronic Eustachian Salpingitis

Intervention / Treatment
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* Device: Balloon dilation of the Eustachian tubes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male or female aged 22 years and older 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. 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. 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 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: Females who are pregnant or lactating 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) Concomitant nasal or sinus procedures planned on the same day as ETBC surgery or any time during study participation (e.g. adenoidectomy, sinus surgery) Concomitant ear procedures planned on the same day as ETBC surgery or any time during study participation (e.g. myringotomy, tympanostomy tube placement) History of major surgery of the head or neck within four (4) months prior to enrollment (e.g. adenoidectomy, sinus surgery) History of a patulous ET in either ear 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 Active chronic or acute otitis media (AOM), in either ear, as evidenced by bulging TM, erythema, purulent effusion, or cholesteatoma Tympanic membrane perforation or presence of a tympanostomy tube in either ear Tympanosclerosis with opacification of ≥50% of tympanic membrane in either ear Evidence of acute upper respiratory infection 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) Cleft palate or history of cleft palate repair Craniofacial syndrome, including Down's Syndrome Cystic fibrosis Ciliary dysmotility syndrome Other systemic mucosal diseases or immunodeficiency disorders (e.g. Samters triad, Sarcoidosis, Wegener's granulomatosis), including patients actively taking immunosuppressive drugs Intolerance of protocol-defined medication regimen Prior surgical intervention on Eustachian tube including balloon dilation, laser or mechanical tuboplasty Absence of dilatory muscular contractions (tensor veli palatini or levator veli palatini failure, severe dysfunction) as assessed by endoscopic observation of swallows and yawns 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 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)

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: prospective, non-significant risk, multi-center, non-controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>Balloon dilation of the Eustachian Tube(s) with Acclarent Aera Balloon | Device: Balloon dilation of the Eustachian tubes<br>* Use the Aera Balloon through the nose to dilate the Eustachian tubes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Pain Assessment Scale to describe procedural pain | 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). | during procedure | 
| Visual Pain Assessment Scale to describe postoperative pain | 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). | 2 weeks after procedure | 
| Visual Pain Assessment Scale to describe postoperative pain | 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). | 6 weeks after procedure | 
| Visual Pain Assessment Scale to describe postoperative pain | 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). | 52 weeks after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tympanometry - an objective measure of the negative pressure in the middle ear | proportion of subjects experiencing normalization of tympanometry post-treatment, indicating improvement or resolution in the negative pressure in the middle ear. | 6 weeks after procedure | 
| Tympanometry - an objective measure of the negative pressure in the middle ear | proportion of subjects experiencing normalization of tympanometry post-treatment, indicating improvement or resolution in the negative pressure in the middle ear. | 52 weeks after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eustachian tube dysfunction