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Completed

NCT Number: NCT02391584

XprESS Eustachian Tube Dilation Study

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

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Key information

Conditions

Eustachian Tube Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado Sinus Institute, Denver, Colorado, United States

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About this study

Prospective, multicenter, randomized controlled trial comparing balloon dilation of the Eustachian tube to continued medical management for treatment of persistent Eustachian tube dysfunction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XprESS

Device

Balloon dilation of the Eustachian tube

Control

Other

Continued medical management

Other names: Continued medical management

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Entellus Medical, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 18, 2015
Registry last updated
Nov 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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