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NCT05719207
Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction
NA trial testing Balloon dilation of eustachian tube in Eustachian Tube Dysfunction in 76 participants. Currently enrolling.
1 December 2025
Quick facts
| Lead sponsor | University of Calgary |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 76 |
| Start date | 25 June 2023 |
| Primary completion | 1 December 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 2 locations across Canada |
Drugs / interventions tested
- Balloon dilation of eustachian tube
- Sham procedure — full drug profile →
Conditions studied
- Eustachian Tube Dysfunction — all drugs for Eustachian Tube Dysfunction →
- Barotitis — all drugs for Barotitis →
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.
Verify or expand the search:
- PubMed search for NCT05719207
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT05275686 — Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD) · Phase 2 · recruiting
- NCT04645511 — Balloon Sinuplasty Efficiency in Maxillary Rhinosinusitis. · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05719207 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Calgary
- Last refreshed: 3 April 2025
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.
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