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Eustachian Tube DysfunctionNCT02391584

XprESS Eustachian Tube Dilation Study

A study testing XprESS in people with Eustachian Tube Dysfunction, run by Entellus Medical, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study to assess the safety and efficacy of the XprESS device for transnasal Eustachian tube dilation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Eustachian Tube Dysfunction
What is being tested?
XprESS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
5 sitesUnited States
Study dates
Feb 2015to Oct 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Austin Ear Clinic

    Austin, Texas, 78758

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Colorado Sinus Institute

    Denver, Colorado, 80210

  • Ear Nose Throat and Sinus Clinic

    North Platte, Nebraska, 69101

  • Donald Guthrie Foundation

    Sayre, Pennsylvania, 18840

Other trials in United States

About this study

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

Read the 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.

Being tested
XprESS, Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XprESSDevice

    Balloon dilation of the Eustachian tube

  • ControlOther

    Also called Continued medical management

    Continued medical management

Study groups in NCT02391584
Study groupRoleWhat they receive
XprESSExperimentalBalloon dilation of the Eustachian tube
Receives: Device: XprESS
ControlOtherContinued medical management
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Mean Overall ETDQ-7 Scores

    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.

    Measured: 6 weeks post procedure (treatment arm) or randomization (control arm)

  2. Complication Rate

    Number of subjects who experience serious device- or procedure-related adverse events

    Measured: Through 6 months post-procedure

Secondary outcomes (6)

  1. Technical Success Rate

    Percent of successful ET dilations per attempted ET dilations

    Measured: Immediately after procedure

  2. Revision Rate

    Percent of participants undergoing repeat balloon dilation procedure on an ET that was initially treated with an XprESS device

    Measured: 12 months

  3. Mean Change in Overall ETDQ-7 Score

    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.

    Measured: 12 months postdilation

  4. Mean Change in Overall ETDQ-7 Score

    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.

    Measured: 6 months postdilation

  5. Mean Change in Overall ETDQ-7 Score

    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.

    Measured: 3 months postdilation

  6. Mean Change in Overall ETDQ-7 Score

    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.

    Measured: 6 weeks postdilation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionMar 2017
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02391584
Sponsor's protocol ID
2909-001
Status last verified
Oct 2018
First submitted
9 Mar 2015
Last updated
1 Nov 2018
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Meyer TA, O'Malley EM, Schlosser RJ, Soler ZM, Cai J, Hoy MJ, Slater PW, Cutler JL, Simpson RJ, Clark MJ, Rizk HG, McRackan TR, D'Esposito CF, Nguyen SA. A Randomized Controlled Trial of Balloon Dilation as a Treatment for Persistent Eustachian Tube Dysfunction With 1-Year Follow-Up. Otol Neurotol. 2018 Aug;39(7):894-902. doi: 10.1097/MAO.0000000000001853.

    PubMed 29912819

  • Swords C, Smith ME, Patel A, Norman G, Llewellyn A, Tysome JR. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025 Feb 26;2(2):CD013429. doi: 10.1002/14651858.CD013429.pub2.

    PubMed 40008607

Questions about this trial

What is this clinical trial studying?

A study testing XprESS in people with Eustachian Tube Dysfunction, run by Entellus Medical, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mean Overall ETDQ-7 Scores (time frame: 6 weeks post procedure (treatment arm) or randomization (control arm)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02391584, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2018; AzTrials last refreshed its copy on 27 Oct 2026.

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