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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
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eustachian Tube Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults (over 18 years) with a diagnosis of Eustachian tube dysfunction based on symptoms and abnor-mal tympanogram.
  2. OME and/or TM atelectasis
  3. Type B or C tympanograms
  4. Inability to inflate middle ears by Valsalva maneuver.
  5. Patients performed tympanocentesis and patients underwent tube insertion will be included.

Exclusion Criteria:

  1. Children less than 18 years old.
  2. Patients with an active infection.
  3. Patients with craniofacial abnormalities.
  4. 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

    First Posted
    March 28, 2017
    Last Updated
    October 25, 2017
    Sponsor
    Hillel Yaffe Medical Center
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    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

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    Balloon Dilation of the Eustachian Tube, a Lower Pressure Challenge

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