BDET: Balloon Dilation of the Eustachian Tube

• Sponsor: Sunnybrook Health Sciences Centre (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05270031
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 48.1
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Eustachian Tube Dysfunction	Device: Balloon dilation of the eustachian tube	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Cross Over after 3 months possibleCross Over after 3 months possible
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3 Randomized Controlled Clinical Trial: Balloon Dilation Treatment of the Eustachian Tube Using an Endovascular Balloon
• Actual Study Start Date: Feb 24, 2022
• Anticipated Primary Completion Date: Feb 28, 2025
• Anticipated Study Completion Date: Feb 28, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eustachian tube dilation Surgical Eustachian tube dilation in general anaesthesia	Device: Balloon dilation of the eustachian tube; Balloon dilation of the eustachian tube
No Intervention: Control Group nasal saline spray

Outcome Measures

Primary Outcome Measures

1. Otoscopy, Normal, Retracted or Middle ear effusion [6 weeks]

   Microscopic evaluation of tympanic membrane

2. Otoscopy, Normal, Retracted or Middle ear effusion [3 motnths]

   Microscopic evaluation of tympanic membrane

3. Otoscopy, Normal, Retracted or Middle ear effusion [6 months]

   Microscopic evaluation of tympanic membrane

4. Otoscopy, Normal, Retracted or Middle ear effusion [12 months]

   Microscopic evaluation of tympanic membrane

Secondary Outcome Measures

1. Valsalva maneuver -positive or negative [6 weeks]

   Subjective effectiveness of Valsalva maneuver

2. Valsalva maneuver -positive or negative [3 months]

   Subjective effectiveness of Valsalva maneuver

3. Valsalva maneuver -positive or negative [6 months]

   Subjective effectiveness of Valsalva maneuver

4. Valsalva maneuver -positive or negative [12 months]

   Subjective effectiveness of Valsalva maneuver

5. Tympanogram [3 months]

   Measurement with tympanometer

6. Tympanogram [6 months]

   Measurement with tympanometer

7. Tympanogram [12 months]

   Measurement with tympanometer

8. ETDQ-7 (eustachian tube dilation questionnaire - seven) [6 weeks]

   Questionnaire

9. ETDQ-7 (eustachian tube dilation questionnaire - seven) [3 months]

   Questionnaire

10. ETDQ-7 (eustachian tube dilation questionnaire - seven) [6 months]

    Questionnaire

11. ETDQ-7 (eustachian tube dilation questionnaire - seven) [12 months]

    Questionnaire

12. HUI (Health utility index) [6 weeks]

    Questionnaire

13. HUI (Health utility index) [3 months]

    Questionnaire

14. HUI (Health utility index) [6 months]

    Questionnaire

15. HUI (Health utility index) [12 months]

    Questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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):

1. 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.

2. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunnybrook Health Sciences Center	Toronto	Ontario	Canada

Sponsors and Collaborators

• Sunnybrook Health Sciences Centre

Investigators

• Principal Investigator: Trung N Le, MD, PhD, Sunnybrook Health Sciences Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sunnybrook Health Sciences Centre
• ClinicalTrials.gov Identifier: NCT05270031
• Other Study ID Numbers: 3156
• First Posted: Mar 8, 2022
• Last Update Posted: Mar 8, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dilatation, Pathologic

Study Results

No Results Posted as of Mar 8, 2022