Clinical trial NCT04055714: Feasibility of Balloon Dilation of the Eustachian Tubes Under Local Anesthesia
Official title: Feasibility of Balloon Dilation of the Eustachian Tubes for Dilatory Dysfunction Under Local Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Eustachian Salpingitis
Keywords: Eustachian tube dysfunction
Lead sponsor: Piedmont Ear, Nose, Throat and Related Allergy, PC
Sponsor class: OTHER
Collaborators: name: Acclarent
First posted: 2019-08-14
Enrollment: 25
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, non-significant risk, multi-center, non-controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Visual Pain Assessment Scale to describe procedural pain
timeFrame: during procedure
measure: Visual Pain Assessment Scale to describe postoperative pain
timeFrame: 2 weeks after procedure
measure: Visual Pain Assessment Scale to describe postoperative pain
timeFrame: 6 weeks after procedure
measure: Visual Pain Assessment Scale to describe postoperative pain
timeFrame: 52 weeks after procedure
Secondary outcomes:
measure: Tympanometry - an objective measure of the negative pressure in the middle ear
timeFrame: 6 weeks after procedure
measure: Tympanometry - an objective measure of the negative pressure in the middle ear
timeFrame: 52 weeks after procedure
Other outcomes:
measure: Quality of life assessment using the ETDQ-7 questionnaire
timeFrame: 6 weeks after procedure
measure: Quality of life assessment using the ETDQ-7 questionnaire
timeFrame: 52 weeks after procedure
Locations:
Study officials:
affiliation: Piedmont Ear, Nose, Throat & Related Allergy
name: Karen Hoffmann, MD
role: PRINCIPAL_INVESTIGATOR
References: