Balloon Dilation of the Eustachian Tube

Eustachian Tube Dysfunction Clinical Trial

— BDET  

Official title:

A Phase 3 Randomized Controlled Clinical Trial: Balloon Dilation Treatment of the Eustachian Tube Using an Endovascular Balloon

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05270031
• Other study ID #: 3156
• Status: Terminated
• Phase: N/A
• Start date: February 24, 2022
• Est. completion date: August 28, 2023

Study information

• Verified date: September 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Patients will eustachian tube dysfunction will be asked to participate in the study. They will be randomized to one of two groups group 1 - surgical dilation of the eustachian tube in general anaesthesia group 2 - daily nasal saline spray, twice a day Regular Follow up with Tympanogram and Questionnaire After three months patient in the control group (nasal saline) can switch in the intervention group. Eustachian tube dilation will be carried out with a Health Canada and FDA approved device, usually used for endovascular balloon dilation. It has the same size and pressure properties as the eustachian tube dilation device and has shown a good safety profile in a previous preclinical and clinical pilot study.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Eustachian Tube Dysfunction

Intervention

Device:
• Balloon dilation of the eustachian tube
Balloon dilation of the eustachian tube

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Center	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

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