Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction

NCT ID: NCT05719207

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-25
• Study Completion Date: 2025-12-01

Brief Summary

This study is being conducted to learn more about a procedure, balloon dilation of the eustachian tube, in treating patients with eustachian tube dysfunction. Traditionally, eustachian tube dysfunction is treated with nasal steroid sprays and decongestants, or by placement of ear tubes. However, current evidence suggest that medical options are ineffective, and placement of ear tubes is not risk-free. The investigators are carrying out this research study with the following goals:

1. Determine if balloon dilation of the eustachian tube is superior to a placebo procedure in treating patients with eustachian tube dilatory dysfunction

2. Identify patient variables associated with positive response to balloon dilation of the eustachian tube

3. Re-demonstrate the safety of balloon dilation of the eustachian tube

What does participation in this study involve? Participants in this study will:

• Agree to be randomly assigned to undergo either: balloon dilation of the eustachian tube, or a placebo procedure, with the option to undergo dilation of the eustachian tube 6 weeks later
• Agree to allowing the investigators access to their personal health information
• Complete the following assessments and questionnaires in clinic before undergoing balloon dilation or placebo procedure:

• A questionnaire to assess your eustachian tube dysfunction
• An assessment of the movement of your ear drum (tympanogram)
• A hearing test (audiogram)
• A questionnaire to assess the impact of eustachian tube dysfunction on work/activity
• A questionnaire to assess overall health-related quality of life
• An assessment of the ability to equalize middle ear pressure(s)
• Visual examination of the ear drums
• Repeat the above assessments and questionnaires over the course of four follow-up appointments at 6-, 24-, and 52-weeks after the procedure.

Detailed Description

Adult eustachian tube dilatory dysfunction (ETDD) accounts for over 2 million healthcare visits annually. It can cause longstanding negative middle ear pressure which may lead to otitis media with effusion, tympanic membrane retraction, perforation, middle ear atelectasis and cholesteatoma. Despite this, effective treatments for ETDD are unavailable. Recently, balloon dilation of the eustachian tube (BDET) has gained popularity, where the cartilaginous portion of the Eustachian tube undergoes local dilation with balloon inflation. This technique underwent industry-funded clinical trials in the United States demonstrating its safety and it's superiority to medical management. However, these studies are confounded by industry funding and lack of a blinded control group, the latter of which is critical in a condition where patient-reported outcome measures are relied on. Furthermore, the randomized studies to date do not include patients with baro-challenge ETDD, where symptoms are limited to the context of ambient pressure changes. As such, the investigators opted to perform a non-industry-funded, placebo-controlled trial including both chronic and baro-challenge ETDD patients in a Canadian setting.

Potential participants will be identified as possible study candidates with either chronic ETDD or baro-challenge ETDD, who have failed conservative management. At baseline, participants would undergo pure tone audiometry, tympanometry, and otoscopy. An ETDQ7, ad hoc work/activity impairment questionnaire, and EQ-5D-5L questionnaire would be completed. The patient's ability to equalize their middle ear pressure would be assessed by direct visualization of the tympanic membrane as the patient equalizes their middle ear pressure. For patients with baro-challenge ETDD, a baseline ad hoc questionnaire to quantify their symptoms will be completed as well.

Patients would then be randomized into BDET versus placebo groups. Patients in the experimental group undergoing BDET in-office will undergo dilation after anxiolytic pre-medication, nasal decongestion, as well as topical anesthesia of the lateral tympanic membrane, the eustachian tube orifice, and the nasal cavity. Patients randomized to the placebo group would undergo a similar procedure in-office, but without dilation of the eustachian tube. Patients in the experimental group with contraindication to in-office BDET will undergo BDET under general anesthetic in an operating room setting. The participants' first follow-up visit with the surgeon is at 6 weeks post-procedure, where patients in the placebo control group would be offered the option to cross-over into the BDET group. Follow up would also be repeated at 24 weeks and 52 weeks post-procedure.

Conditions

Eustachian Tube Dysfunction; Barotitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Balloon dilation of eustachian tube

These patient will undergo balloon dilation dilation of the eustachian tube.

Group Type: EXPERIMENTAL

Balloon dilation of eustachian tube

Intervention Type: DEVICE

Patients in the intervention group would undergo balloon dilation of the eustachian tube under local anesthetic in clinic. The Stryker XprESS LoProfile ENT dilation system or the Stryker Audion ET dilation system will be used.

Sham procedure

These patients will undergo a sham procedure, where the motions of balloon dilation of the eustachian tube will be simulated.

Group Type: SHAM_COMPARATOR

Sham procedure

Intervention Type: OTHER

Patients in the sham group will undergo the motions of an in-office dilation of the eustachian tube, without actually dilating the eustachian tube.

Interventions

Balloon dilation of eustachian tube

Patients in the intervention group would undergo balloon dilation of the eustachian tube under local anesthetic in clinic. The Stryker XprESS LoProfile ENT dilation system or the Stryker Audion ET dilation system will be used.

Intervention Type: DEVICE

Sham procedure

Patients in the sham group will undergo the motions of an in-office dilation of the eustachian tube, without actually dilating the eustachian tube.

Intervention Type: OTHER

Other Intervention Names

Stryker XprESS LoProfile ENT dilation system (Stryker ENT, Plymouth, MN, USA.); Stryker Audion ET dilation system (Stryker ENT, Plymouth, MN, USA)

Eligibility Criteria

Inclusion Criteria

• >3 months of symptoms of ETDD (otalgia, ear pressure, muffled hearing, tinnitus, cracking or popping, feeling clogged) persistent at enrollment
• Persistence of symptoms despite >4 weeks INCS or >7d course of systemic steroid within 6 months from enrollment
• Documented Type B or C tympanogram at or within 6 months from enrollment
• ETDQ7 ≥ 2.1 at enrollment

• >12 months of baro-challenge induced symptoms occurring at least every 4 months within the past year
• Symptoms include otalgia, ear pressure, muffled hearing, tinnitus, cracking or popping, feeling clogged, vertigo, or facial nerve palsy, which resolve within 3 days of pressure equalization.
• Failure of at least one of: topical/oral decongestant, pneumatization device, and/or pressure relief ear plugs.

Exclusion Criteria

• Signs/symptoms of patulous eustachian tube dysfunction (autophony, tympanic membrane movement with breathing)
• Adjunctive surgical procedure needed (ex. septoplasty, tympanostomy tube)
• Presence of a tympanic membrane (TM) perforation or tympanostomy tube
• Fluctuating SNHL, AOM, grade IV TM retraction, or tympanosclerosis of >50% of the TM
• Uncontrolled sino-nasal disease, reflux, TMJ disorder, immunodeficiency, or allergies
• Known ICA dehiscence of the bony ET of the symptomatic ear
• Recent head and neck surgery within the past 3 months or planned procedure during study
• History of radiation to the head and neck
• History of craniofacial abnormality
• Prior ET intervention
• Psychiatric condition or cognitive impairment which precludes capacity to consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Justin Lui

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Justin Lui, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Otology Clinic, Clinic 7A, South Health Campus

Calgary, Alberta, Canada

Site Status: RECRUITING

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jaimi Workun

Role: CONTACT

jaimi.workun@albertahealthservices.ca

403-764-4755 ext. 4

Mohammad Aleinati, MD

Role: CONTACT

maleinat@ucalgary.ca

587-573-4364

Facility Contacts

Justin Lui, MD

Role: primary

justin.lui@ucalgary.ca

Trung Le, MD, PhD, FRCSC

Role: primary

trung.le@sunnybrook.ca

Other Identifiers

REB22-1601

Identifier Type: -

Identifier Source: org_study_id