Balloon Dilation of the Eustachian Tube, a Lower Pressure Challenge
Primary Purpose
Eustachian Tube Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Balloon dilatation Eustachian tuboplasty
Sponsored by
About this trial
This is an interventional treatment trial for Eustachian Tube Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Adults (over 18 years) with a diagnosis of Eustachian tube dysfunction based on symptoms and abnor-mal tympanogram.
- OME and/or TM atelectasis
- Type B or C tympanograms
- Inability to inflate middle ears by Valsalva maneuver.
- Patients performed tympanocentesis and patients underwent tube insertion will be included.
Exclusion Criteria:
- Children less than 18 years old.
- Patients with an active infection.
- Patients with craniofacial abnormalities.
- Pregnancy?
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with Eustachian tube dysfunction
Arm Description
Outcomes
Primary Outcome Measures
The change in eustachian tube function
Otoscopy
Secondary Outcome Measures
Full Information
NCT ID
NCT03322579
First Posted
March 28, 2017
Last Updated
October 25, 2017
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03322579
Brief Title
Balloon Dilation of the Eustachian Tube, a Lower Pressure Challenge
Official Title
Balloon Dilation of the Eustachian Tube, a Lower Pressure Challenge
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2017 (Anticipated)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
Balloon dilatation Eustachian tuboplasty has recently become a promising procedure for the treatment of refractory dilatory dysfunction of the Eustachian tube.
Eustachian tube (ET) comprises an osseous intratemporal portion and a cartilaginous nasopharyngeal portion. It functions in pressure equalization, middle ear protection and clearance. Eustachian tube function can be adversely affected by viral and bacterial infections, adenoid disease, craniofacial anomalies, neoplasm, genetic predisposition, sinonasal disease and gastroesophageal reflux, leading to Eustachian tube dysfunction. Eustachian tuboplasty by balloon dilation involves the recanalization of the cartilaginous portion of the ET via the nasopharynx with a balloon catheter. This catheter is inflated to multiple atmospheres of pressure for a short amount of time and then removed.
The surgical technique, the optimal balloon diameter, pressure or duration of inflation are variable in the literature.
Even though the current data shows promising results and a potential benefit of this procedure, further evaluation is still needed in order to establish a higher level of evidence of efficacy and safety.
Detailed Description
Balloon dilatation Eustachian tuboplasty has recently become a promising procedure for the treatment of refractory dilatory dysfunction of the Eustachian tube.
Eustachian tube (ET) comprises an osseous intratemporal portion and a cartilaginous nasopharyngeal portion. It functions in pressure equalization, middle ear protection and clearance. Eustachian tube function can be adversely affected by viral and bacterial infections, adenoid disease, craniofacial anomalies, neoplasm, genetic predisposition, sinonasal disease and gastroesophageal reflux, leading to Eustachian tube dysfunction.
it is now well known that the site of pathology is usually in the cartilaginous portion and not within the osseus portion.
Chronic dilatory dysfunction of the Eustachian tube is estimated to be 1% of the adult population. Current medical and surgical treatment options for this pathophysiological disorder is still unsatisfactory, including nasal decongestants, topical and systematic corticosteroids, antihistamines and multiple insertions of ventilation tubes leading to complications.
ET dysfunction can lead to impaired quality of life due to persistent sensation of ear fullness, ear pain and inability to tolerate air travel, diving or other activities. With time, Eustachian tube dysfunction, if left untreated can lead to complications such as conductive hearing loss and cholesteatoma formation. Recently, numerous researches have investigated the role of balloon tuboplasty. This procedure aims to ventilate and drain the middle ear by improving the physiological function of the eustachian tube and treating chronic refractory eustachian tube dysfunction.
Eustachian tuboplasty by balloon dilation involves the recanalization of the cartilaginous portion of the ET via the nasopharynx with a balloon catheter. This catheter is inflated to multiple atmospheres of pressure for a short amount of time and then removed.
The surgical technique, the optimal balloon diameter, pressure or duration of inflation are variable in the literature.
Both cadaveric and clinical studies where done. Cadaveric studies revealed no evidence of fractures to the cartilaginous or bony lumen, and no damage to the internal carotid artery. Several clinical studies and many others that confirm the safety of eustachian tube balloon dilation and consider it as a potential solution for chronic eustachian tube dysfunction. A systematic review preformed in 2014 showed no adverse outcomes in 103 patients who had undergone balloon dilation of the Eustachian tube. Another more recent systematic review in 2016 that included nine prospective studies, describing 713 eustachian tube balloon dilations in 474 patients confirm the safety of eustachian tube balloon dilation.
In September 2016 the ACCLARENT AERA™ Eustachian Tube Balloon Dilation System, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of Eustachian Tube Dysfunction (ETD) and was permitted for marketing.
Even though the current data shows promising results and a potential benefit of this procedure, further evaluation is still needed in order to establish a higher level of evidence of efficacy and safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eustachian Tube Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Unilateral or bilateral balloon catheter dilation will be performed on patients with eustachian tube dysfunction
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with Eustachian tube dysfunction
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Balloon dilatation Eustachian tuboplasty
Intervention Description
Eustachian tuboplasty by balloon dilation involves the recanalization of the cartilaginous portion of the ET via the nasopharynx with a balloon catheter. This catheter is inflated to multiple atmospheres of pressure for a short amount of time and then removed.
Primary Outcome Measure Information:
Title
The change in eustachian tube function
Description
Otoscopy
Time Frame
1,3,6 and 12 month post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults (over 18 years) with a diagnosis of Eustachian tube dysfunction based on symptoms and abnor-mal tympanogram.
OME and/or TM atelectasis
Type B or C tympanograms
Inability to inflate middle ears by Valsalva maneuver.
Patients performed tympanocentesis and patients underwent tube insertion will be included.
Exclusion Criteria:
Children less than 18 years old.
Patients with an active infection.
Patients with craniofacial abnormalities.
Pregnancy?
12. IPD Sharing Statement
Learn more about this trial
Balloon Dilation of the Eustachian Tube, a Lower Pressure Challenge
We'll reach out to this number within 24 hrs