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Feasibility of Balloon Dilation of the Eustachian Tubes Under Local Anesthesia

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ClinicalTrials.gov Identifier: NCT04055714
Recruitment Status : Not yet recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Acclarent
Information provided by (Responsible Party):
Piedmont Ear, Nose, Throat and Related Allergy, PC

Study Description
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Brief Summary:
The objective of this study is to demonstrate that balloon dilation of the Eustachian tubes can be done successfully for treatment of chronic dilatory Eustachian tube dysfunction under local anesthesia with acceptable patient discomfort levels.

Condition or disease Intervention/treatment Phase
Chronic Eustachian Salpingitis Device: Balloon dilation of the Eustachian tubes Not Applicable

Detailed Description:
This study is a prospective, non-significant risk, multi-center trial of patients with Eustachian tube dysfunction who are refractory to medical management. Patients will undergo balloon dilation of the Eustachian tubes in the office under local anesthesia. We will assess assess the peri-procedural and post-procedure pain levels, and determine the proportion of subjects experiencing normalization of tympanometry and improvement in quality of of life at 6 weeks, 12 weeks, and 52 weeks post-treatment.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: prospective, non-significant risk, multi-center, non-controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Balloon Dilation of the Eustachian Tubes for Dilatory Dysfunction Under Local Anesthesia
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment arm
Balloon dilation of the Eustachian Tube(s) with Acclarent Aera Balloon
 Device: Balloon dilation of the Eustachian tubes
Use the Aera Balloon through the nose to dilate the Eustachian tubes


Outcome Measures
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Primary Outcome Measures :
  1. Visual Pain Assessment Scale to describe procedural pain [ Time Frame: during procedure ]
    Assess peri-procedural pain levels with a visual pain assessment scale. The scale has numbering from 0-10 with associated visual pictures that correspond to the degree of pain. Participants will number their pain level and describe the location of pain (ear, nose, forehead, jaw, teeth).

  2. Visual Pain Assessment Scale to describe postoperative pain [ Time Frame: 2 weeks after procedure ]
    Assess post-procedural pain levels with a visual pain assessment scale. The scale has numbering from 0-10 with associated visual pictures that correspond to the degree of pain. Participants will number their pain level and describe the location of pain (ear, nose, forehead, jaw, teeth).

  3. Visual Pain Assessment Scale to describe postoperative pain [ Time Frame: 6 weeks after procedure ]
    Assess post-procedural pain levels with a visual pain assessment scale. The scale has numbering from 0-10 with associated visual pictures that correspond to the degree of pain. Participants will number their pain level and describe the location of pain (ear, nose, forehead, jaw, teeth).

  4. Visual Pain Assessment Scale to describe postoperative pain [ Time Frame: 52 weeks after procedure ]
    Assess post-procedural pain levels with a visual pain assessment scale. The scale has numbering from 0-10 with associated visual pictures that correspond to the degree of pain. Participants will number their pain level and describe the location of pain (ear, nose, forehead, jaw, teeth).


Secondary Outcome Measures :
  1. Tympanometry - an objective measure of the negative pressure in the middle ear [ Time Frame: 6 weeks after procedure ]
    proportion of subjects experiencing normalization of tympanometry post-treatment, indicating improvement or resolution in the negative pressure in the middle ear.

  2. Tympanometry - an objective measure of the negative pressure in the middle ear [ Time Frame: 52 weeks after procedure ]
    proportion of subjects experiencing normalization of tympanometry post-treatment, indicating improvement or resolution in the negative pressure in the middle ear.


Other Outcome Measures:
  1. Quality of life assessment using the ETDQ-7 questionnaire [ Time Frame: 6 weeks after procedure ]
    Determine the proportion of subjects achieving improvement of 0.5 points at 6 weeks post-treatment, indicating significant improvement in the quality of life with respect to symptoms of Eustachian tube dysfunction.

  2. Quality of life assessment using the ETDQ-7 questionnaire [ Time Frame: 52 weeks after procedure ]
    Determine the proportion of subjects achieving improvement of 0.5 points at 6 weeks post-treatment, indicating significant improvement in the quality of life with respect to symptoms of Eustachian tube dysfunction.


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adult male or female aged 22 years and older
  2. Persistent ETD as defined by patient-reported symptoms of ETD (including pressure and/or pain and/or clogged and/or muffled sensation in the affected ear(s)) for no less than 12 weeks prior to enrollment, and at least one of the following confirmatory indicators of persistent ETD no less than 12 weeks prior to enrollment B1: Confirmation from referring physician that the subject has experienced persistent ETD symptoms (including pressure and/or pain and/or clogged and or muffled sensation in the affected ear(s)) during an office visit no less than 12 weeks prior to enrollment. Persistent symptoms must be confirmed as not waxing and waning. OR B2: Documented evidence in the ENT physician records that the subject has experienced persistent ETD symptoms (including pressure and/or pain and/or clogged and/or muffled sensation in the affected ear(s)) during an office visit no less than 12 weeks prior to enrollment. Persistent symptoms must be confirmed as not waxing and waning. OR B3: Type B or Type C tympanogram in at least one ear no less than 12 weeks prior to enrollment. OR B4: Otoscopic exam demonstrating TM retraction and/or middle ear fluid no less than 12 weeks prior to enrollment.
  3. Failure of appropriate medical management consisting of either a minimum of 4 weeks of continuous daily usage of any intranasal steroid spray (INS) or a minimum of one completed course of an oral steroid, per the investigator's choice. The failed medical management may occur any time within 90 days prior to study enrollment.

  4. A positive diagnosis of persistent (i.e. not waxing and waning) ETD, as confirmed with both of the following:

    D1: Abnormal tympanometry (defined as either Type B or Type C) after failed medical management and within 14 days of study enrollment D2: Symptomatic dysfunction as documented by a Eustachian Tube Dysfunction Questionnaire (ETDQ-7) mean item score ≥ 2.1 after failed medical management

  5. Absence of internal carotid artery (ICA) dehiscence into the ET lumen on both sides as confirmed by a computed tomography (CT scan) including temporal bone - to include paranasal sinuses when clinically appropriate

Exclusion Criteria:

  1. Females who are pregnant or lactating
  2. Anatomy that requires an adjunctive surgical procedure on the same day as ETBC surgery to allow balloon catheter access to the ET (e.g. septoplasty, polypectomy, turbinate reduction)
  3. Concomitant nasal or sinus procedures planned on the same day as ETBC surgery or any time during study participation (e.g. adenoidectomy, sinus surgery)
  4. Concomitant ear procedures planned on the same day as ETBC surgery or any time during study participation (e.g. myringotomy, tympanostomy tube placement)
  5. History of major surgery of the head or neck within four (4) months prior to enrollment (e.g. adenoidectomy, sinus surgery)
  6. History of a patulous ET in either ear
  7. History of fluctuating sensorineural hearing loss, in either ear, within the past 5 years, as evidenced by a 20dB change in 3 pure tone average frequencies
  8. Active chronic or acute otitis media (AOM), in either ear, as evidenced by bulging TM, erythema, purulent effusion, or cholesteatoma
  9. Tympanic membrane perforation or presence of a tympanostomy tube in either ear
  10. Tympanosclerosis with opacification of ≥50% of tympanic membrane in either ear
  11. Evidence of acute upper respiratory infection
  12. Evidence of active Temporomandibular joint disorder (TMJ) per clinical exam (i.e. pain with mouth opening, chewing, clenching; tenderness to palpation deep into the glenoid capsule on wide mouth opening, especially with right and left lateral movements of the jaw; tenderness of the masseter or lateral pterygoid muscles on bimanual intra/extraoral examination)
  13. Cleft palate or history of cleft palate repair
  14. Craniofacial syndrome, including Down's Syndrome
  15. Cystic fibrosis
  16. Ciliary dysmotility syndrome
  17. Other systemic mucosal diseases or immunodeficiency disorders (e.g. Samters triad, Sarcoidosis, Wegener's granulomatosis), including patients actively taking immunosuppressive drugs
  18. Intolerance of protocol-defined medication regimen
  19. Prior surgical intervention on Eustachian tube including balloon dilation, laser or mechanical tuboplasty
  20. Absence of dilatory muscular contractions (tensor veli palatini or levator veli palatini failure, severe dysfunction) as assessed by endoscopic observation of swallows and yawns
  21. Treatment is planned for one ear, but the opposite ear has normal (Type A) tympanogram and the subject complains of ETD symptoms in that ear
  22. Treatment is planned for one ear, but the opposite ear has abnormal (Type B or C) tympanogram and the subject has no complaints of ETD symptoms in that ear (asymptomatic)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055714


Contacts
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Contact: Study Coordinator 404-351-5045 PiedmontENTResearch@piedent.com
Contact: Principal Investigator 404-351-5045 DrHoffmannResearch@piedent.com

Sponsors and Collaborators
Piedmont Ear, Nose, Throat and Related Allergy, PC
Acclarent
Investigators
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Principal Investigator: Karen Hoffmann, MD Piedmont Ear, Nose, Throat & Related Allergy
More Information
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Responsible Party: Piedmont Ear, Nose, Throat and Related Allergy, PC
ClinicalTrials.gov Identifier: NCT04055714    
Other Study ID Numbers: IIS A-016
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Piedmont Ear, Nose, Throat and Related Allergy, PC:
Eustachian tube dysfunction
Additional relevant MeSH terms:
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Salpingitis
Fallopian Tube Diseases
Adnexal Diseases
Pelvic Inflammatory Disease