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

NCT05719207 | Recruiting FDA Device

• 1 other identifier: REB22-1601
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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:

• 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.

Conditions

Eustachian Tube Dysfunction; Barotitis

Keywords

BDET; ETD; ETDD; baro-challenge

Outcome Measures

Primary Outcomes (2)

• Change in mean Eustachian Tube Dysfunction Questionnaire (ETDQ7) score

  Score range 1-7, with higher score indicating more severe symptoms

  6 weeks, 24 weeks, and 52 weeks post-intervention

• Change in symptoms (ad hoc baro-challenge ETDD symptom questionnaire)

  Composite of quantitative and qualitative data points

  6 weeks, 24 weeks, and 52 weeks post-intervention

Secondary Outcomes (5)

• Change in tympanogram type and pressure at peak compliance

  6 weeks, 24 weeks, and 52 weeks post-intervention

• Change in audiogram (pure tone average thresholds)

  24 weeks

• Improvement in ability to equalize middle ear pressure

  6 weeks, 24 weeks, and 52 weeks post-intervention

• Tympanic membrane position on otoscopy

  6 weeks, 24 weeks, and 52 weeks post-intervention

• Ad hoc work/activity impairment questionnaire score

  6 weeks, 24 weeks, and 52 weeks post-intervention

Study Arms (2)

Balloon dilation of eustachian tube

EXPERIMENTAL

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

Device: Balloon dilation of eustachian tube

Sham procedure

SHAM COMPARATOR

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

Other: Sham procedure

Interventions

Balloon dilation of eustachian tube 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.

Also known as: Stryker XprESS LoProfile ENT dilation system (Stryker ENT, Plymouth, MN, USA.), Stryker Audion ET dilation system (Stryker ENT, Plymouth, MN, USA)

Balloon dilation of eustachian tube

Sham procedure 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.

Sham procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (2)

Otology Clinic, Clinic 7A, South Health Campus

Calgary, Alberta, Canada

RECRUITING

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

RECRUITING

Study Officials

• Justin Lui, MD, FRCSC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaimi Workun

CONTACT

403-764-4755; jaimi.workun@albertahealthservices.ca

Mohammad Aleinati, MD

CONTACT

587-573-4364; maleinat@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel design with optional crossover from control to intervention at 6 weeks.

Study Record Dates

• First Submitted: January 15, 2023
• First Posted: February 8, 2023
• Study Start: June 25, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)