Eustachian Tube Dysfunction Clinical Trial
— BDETOfficial title:
A Phase 3 Randomized Controlled Clinical Trial: Balloon Dilation Treatment of the Eustachian Tube Using an Endovascular Balloon
NCT number | NCT05270031 |
Other study ID # | 3156 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | February 24, 2022 |
Est. completion date | August 28, 2023 |
Verified date | September 2023 |
Source | Sunnybrook Health Sciences Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, patients with dysfunction of the eustachian tube will be included. They will be randomized to one of two treatment groups. 1. balloon dilation of the eustachian tube or 2. nasal saline Patients will undergo follow-up for one year and will be able to crossover to the treatment arm after three months
Status | Terminated |
Enrollment | 15 |
Est. completion date | August 28, 2023 |
Est. primary completion date | May 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - =18 years old (of both sexes) - Diagnosed with persistent obstructive eustachian tube dysfunction (OETD) for at least 3 months prior to enrolment uni- and/or bilateral Diagnosis (both required): i. Persistent OETD symptoms assessed by Eustachian Tube Dysfunction Questionnaire (ETDQ-7) with overall score of =3 (moderate to severe symptoms) for 3 months or more prior to enrollment. ii. Refractory to medical therapy (minimum of 4 weeks of daily intranasal steroid spray or one completed course of an oral steroid within 3 months before study enrollment). Exclusion Criteria: - Patulous eustachian tube - Prior eustachian tube intervention - Presence of myringotomy ventilation tube or a tympanic membrane perforation - Active chronic or acute otitis media - Chronic otitis media with cholesteatoma - Fluctuating sensorineural hearing loss or Meniere's disease - Chronic rhinosinusitis, allergies, or reflux disease not controlled with medication - History of head or neck surgery within 3 months - Prior radiation to the head and neck - Active temporomandibular joint disorders - Cleft palate or Craniofacial syndrome - Cystic fibrosis or Ciliary dysmotility syndrome or Systemic immunodeficiencies - Active acute upper respiratory infection - Nasal endoscopy with evidence of anatomic conditions that would prevent transnasal access to the Eustachian tube - CT temporal bone scan with evidence of carotid artery dehiscence, superior semicircular canal dehiscence, or extrinsic eustachian tube compression - Patient unable to follow protocol for any reason |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Center | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Otoscopy, Normal, Retracted or Middle ear effusion | Microscopic evaluation of tympanic membrane | 6 weeks | |
Primary | Otoscopy, Normal, Retracted or Middle ear effusion | Microscopic evaluation of tympanic membrane | 3 motnths | |
Primary | Otoscopy, Normal, Retracted or Middle ear effusion | Microscopic evaluation of tympanic membrane | 6 months | |
Primary | Otoscopy, Normal, Retracted or Middle ear effusion | Microscopic evaluation of tympanic membrane | 12 months | |
Secondary | Valsalva maneuver -positive or negative | Subjective effectiveness of Valsalva maneuver | 6 weeks | |
Secondary | Valsalva maneuver -positive or negative | Subjective effectiveness of Valsalva maneuver | 3 months | |
Secondary | Valsalva maneuver -positive or negative | Subjective effectiveness of Valsalva maneuver | 6 months | |
Secondary | Valsalva maneuver -positive or negative | Subjective effectiveness of Valsalva maneuver | 12 months | |
Secondary | Tympanogram | Measurement with tympanometer | 3 months | |
Secondary | Tympanogram | Measurement with tympanometer | 6 months | |
Secondary | Tympanogram | Measurement with tympanometer | 12 months | |
Secondary | ETDQ-7 (eustachian tube dilation questionnaire - seven) | Questionnaire | 6 weeks | |
Secondary | ETDQ-7 (eustachian tube dilation questionnaire - seven) | Questionnaire | 3 months | |
Secondary | ETDQ-7 (eustachian tube dilation questionnaire - seven) | Questionnaire | 6 months | |
Secondary | ETDQ-7 (eustachian tube dilation questionnaire - seven) | Questionnaire | 12 months | |
Secondary | HUI (Health utility index) | Questionnaire | 6 weeks | |
Secondary | HUI (Health utility index) | Questionnaire | 3 months | |
Secondary | HUI (Health utility index) | Questionnaire | 6 months | |
Secondary | HUI (Health utility index) | Questionnaire | 12 months |
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