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XprESS Eustachian Tube Dilation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02391584
Recruitment Status : Completed
First Posted : March 18, 2015
Results First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Entellus Medical, Inc.

Study Description
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Brief Summary:
Study to assess the safety and efficacy of the XprESS device for transnasal Eustachian tube dilation.

Condition or disease Intervention/treatment Phase
Eustachian Tube Dysfunction Device: XprESS Other: Control Not Applicable

Detailed Description:
Prospective, multicenter, randomized controlled trial comparing balloon dilation of the Eustachian tube to continued medical management for treatment of persistent Eustachian tube dysfunction.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: XprESS Eustachian Tube Dilation Study
Study Start Date : February 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : October 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: XprESS
Balloon dilation of the Eustachian tube
 Device: XprESS
Balloon dilation of the Eustachian tube
Control
Continued medical management
 Other: Control
Continued medical management
Other Name: Continued medical management


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Mean Overall ETDQ-7 Scores [ Time Frame: 6 weeks post procedure (treatment arm) or randomization (control arm) ]

    Comparison of mean change in overall ETDQ-7 scores from baseline to 6 weeks between randomized arms.

    The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity. The 7 items are: pressure in the ears, pain in the ears, a feeling that your ears are clogged or underwater, ear symptoms when you have a cold of sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that your hearing is muffled. Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7). Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms.


  2. Complication Rate [ Time Frame: Through 6 months post-procedure ]
    Number of subjects who experience serious device- or procedure-related adverse events


Secondary Outcome Measures :
  1. Technical Success Rate [ Time Frame: Immediately after procedure ]
    Percent of successful ET dilations per attempted ET dilations

  2. Revision Rate [ Time Frame: 12 months ]
    Percent of participants undergoing repeat balloon dilation procedure on an ET that was initially treated with an XprESS device

  3. Mean Change in Overall ETDQ-7 Score [ Time Frame: 12 months postdilation ]
    Mean change from baseline to 12 months in the overall ETDQ-7 score. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity. The 7 items are: pressure in the ears, pain in the ears, a feeling that your ears are clogged or underwater, ear symptoms when you have a cold of sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that your hearing is muffled. Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7). Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms.

  4. Mean Change in Overall ETDQ-7 Score [ Time Frame: 6 months postdilation ]
    Mean change from baseline to 6 months in the overall ETDQ-7 score. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity. The 7 items are: pressure in the ears, pain in the ears, a feeling that your ears are clogged or underwater, ear symptoms when you have a cold of sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that your hearing is muffled. Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7). Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms.

  5. Mean Change in Overall ETDQ-7 Score [ Time Frame: 3 months postdilation ]
    Mean change from baseline to 3 months in the overall ETDQ-7 score. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity. The 7 items are: pressure in the ears, pain in the ears, a feeling that your ears are clogged or underwater, ear symptoms when you have a cold of sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that your hearing is muffled. Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7). Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms.

  6. Mean Change in Overall ETDQ-7 Score [ Time Frame: 6 weeks postdilation ]
    Mean change from baseline to 6 weeks in the overall ETDQ-7 score. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity. The 7 items are: pressure in the ears, pain in the ears, a feeling that your ears are clogged or underwater, ear symptoms when you have a cold of sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that your hearing is muffled. Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7). Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥18 years old
  • Have been diagnosed with symptoms of chronic Eustachian tube dysfunction for no less than 12 months prior to enrollment
  • Have an overall ETDQ-7 score ≥3.0
  • Have record of failed medical management for Eustachian tube dysfunction

Exclusion Criteria:

  • Require concomitant procedures at the time of the study enrollment or procedure
  • Have patulous Eustachian tube
  • Have ear tubes in place or perforation of the tympanic membrane
  • Have evidence of internal carotid artery dehiscence
  • Be pregnant at the time of enrollment
  • Be currently participating in other drug or device studies
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): NCT02391584


Locations
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United States, Colorado
Colorado Sinus Institute
Denver, Colorado, United States, 80210
United States, Nebraska
Ear Nose Throat and Sinus Clinic
North Platte, Nebraska, United States, 69101
United States, Pennsylvania
Donald Guthrie Foundation
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Austin Ear Clinic
Austin, Texas, United States, 78758
Sponsors and Collaborators
Entellus Medical, Inc.
  Study Documents (Full-Text)

Documents provided by Entellus Medical, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] September 15, 2015

More Information
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Publications of Results:

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Responsible Party: Entellus Medical, Inc.
ClinicalTrials.gov Identifier: NCT02391584    
Other Study ID Numbers: 2909-001
First Posted: March 18, 2015    Key Record Dates
Results First Posted: November 1, 2018
Last Update Posted: November 1, 2018
Last Verified: October 2018
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
Additional relevant MeSH terms:
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Dilatation, Pathologic
Pathological Conditions, Anatomical