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NCT05719207

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

Recruiting now NA Last updated 3 April 2025
What this trial tests

NA trial testing Balloon dilation of eustachian tube in Eustachian Tube Dysfunction in 76 participants. Currently enrolling.

Timeline
25 June 2023
Primary endpoint
1 December 2025
1 December 2025

Quick facts

Lead sponsorUniversity of Calgary
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment76
Start date25 June 2023
Primary completion1 December 2025
Estimated completion1 December 2025
Sites2 locations across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University of Calgary

Who can join

18 and older, any sex, with Eustachian Tube Dysfunction or Barotitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Eustachian Tube Dysfunction

Currently open trials in the same condition.

Other University of Calgary trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05719207.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing