Eustachian Tube Dilation With an Endovascular Balloon | NCT04809753

Studies
Eustachian Tube Dilation With an Endovascular Balloon

NCT04809753

Sponsor

Sunnybrook Health Sciences Centre

Status

Completed

Last Update Posted

Oct 26, 2022Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Eustachian Tube Dysfunction
Eustachian Tube Dysfunction of Both Ears

Interventions

Eustachian tube dilation

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 29, 2021Actual

Primary Completion Date

Aug 20, 2021Actual

Completion Date

Feb 28, 2022Actual

First Submitted Date

Feb 24, 2021

First Submission Date that Met QC Criteria

Mar 18, 2021

First Posted Date

Mar 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2022

Last Update Posted Date

Oct 26, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Eustachian tube is a narrow tube which links the back of the nose to the middle ear. Eustachian tube dysfunction may occur when the mucosal lining of the tube is swollen, or does not open or close properly. It can occur after the start of a cold and other nose, sinus, ear and throat infections causing ear pain and pressure, fullness, cracking/popping sounds. This is an ubiquitous healthcare problem, affecting children and adults, that can lead to severe consequences including hearing loss, chronic otitis media, tinnitus, and vertigo. Numerous studies have consistently failed to support the effectiveness of medical managements. Pressure equalizing tubes are considered a temporary solution that does not treat the underlying pathology. More recent preliminary evidence of using inflation of a noncompressible balloon in the eustachian tube improved clinical outcomes, patients' symptoms and quality of life. This eustachian dilation catheter is not accessible in Canada since the device and procedure is not covered by OHIP (Ontario health insurance plan) or any other health insurance in Canada. In a cadaver study, we have evaluated using an endovascular balloon (Balloon that is used to dilate (expand) vessels) for eustachian tube dilation, which only costs about 10% of the eustachian tube dilation device. This endovascular balloon is Health Canada approved, but not for this specific use. We therefore want to conduct a pilot safety study with the main goal of assessing feasibility of eustachian tube dilation with the endovascular device.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Eustachian tube dilation	Experimental	Eustachian tube dilation with an endovascular balloon	Device: Eustachian tube dilation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eustachian tube dilation	Device	Dilation of the eustachian tube with an endovascular balloon	Eustachian tube dilation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Succesfull procedure	o Feasibility to perform the procedure after ear surgery with no local complication and within 15-20 minutes	20 minutes

Secondary Outcomes

Measure	Description	Time Frame
CT	o Safety evaluated after the procedure CT scan. Complications (adverse and serious adverse events related to the device or procedure)	5 minutes
ETDQ - 7 (Eustachian Tube Dysfunction Questionnaire - Item 7)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥18 years old (of both sexes)
Diagnosed with unilateral or bilateral persistent obstructive eustachian tube dysfunction (OETD)
Undergoing tympanoplasty or tympanomastoidectomy

Exclusion Criteria:

Patulous eustachian tube
Preoperative 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
Cleft palate or Craniofacial syndrome
Prior eustachian tube intervention
Prior radiation to the head and neck

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Trung Le, MD	Sunnybrook Health Sciences Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sunnybrook Health Sciences Center		Toronto	Ontario	M4N 3M5	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36855202	Derived	Dahm V, Lui JT, Jung S, Lin VY, Chen JM, Le TN. The feasibility and safety of eustachian tube dilation with a standard endovascular balloon: a clinical pilot study. J Otolaryngol Head Neck Surg. 2023 Feb 28;52(1):20. doi: 10.1186/s40463-022-00599-1.