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Eustachian Tube DysfunctionNCT04136977

XprESS ET Registry

An observational study of Eustachian Tube Dysfunction, run by Entellus Medical, Inc. at 11 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

A prospective, multicenter, registry of patients undergoing balloon dilation of the Eustachian tubes (ET). 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?
Eustachian tube dilation
Type of treatment
Medical device
How many people
169 participants
Where
11 sitesUnited States
Study dates
5 Jun 2018to 28 Aug 2020
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

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

Study population: Adult patients with persistent/chronic Eustachian tube dysfunction who are undergoing balloon dilation of the Eustachian tubes.

Who may be able to join

  • Be at least 18 years old
  • Have been diagnosed with persistent/chronic Eustachian tube dysfunction (duration 3 months or more)
  • Be a candidate for unilateral or bilateral Eustachian tube balloon dilation using the XprESS device
  • Be able to read and understand English
  • Be willing and able to provide informed consent
  • Be willing to comply with the protocol requirements

Who cannot join

  • Have a history of patulous Eustachian tube
  • Require additional ear surgery (eg, myringotomy, tympanostomy) at the time of study procedure
  • Have evidence of internal carotid artery dehiscence
  • Be currently participating in any other drug or device clinical studies, excluding postapproval or marketing registry studies

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • St. Vincent Anderson Hospital

    Anderson, Indiana, 46016

  • Lakeside ENT

    Canandaigua, New York, 14424

  • National Allergy and ENT

    Charleston, South Carolina, 29420

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Colorado ENT and Allergy

    Colorado Springs, Colorado, 80909

  • Augusta ENT and Allergy

    Evans, Georgia, 30809

  • ENT Consultants of Nevada

    Las Vegas, Nevada, 89128

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • St Cloud ENT

    Saint Cloud, Minnesota, 56303

  • Ear Nose and Throat Consultants

    Southfield, Michigan, 48934

  • Breathe Clear Institute

    Torrance, California, 90503

Other trials in United States

About this study

Official title: XprESS Eustachian Tube Balloon Dilation Registry

A prospective, multicenter, registry of patients undergoing balloon dilation of the Eustachian tubes (ET).

Read the detailed description

This is a prospective, multicenter, single-arm, postmarket registry enrolling up to 300 participants who are planning to undergo balloon dilation of the Eustachian tubes for treatment of chronic/persistent Eustachian tube dysfunction (ETD). Procedural information will be collect as well as efficacy and safety data through 6 months post procedure.

Being tested
Eustachian tube dilation

What participants receive

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

  • Eustachian tube dilationDevice

    Also called XprESS ET balloon dilation

    Unilateral or bilateral balloon dilation of the Eustachian tube using the FDA-cleared XprESS ENT Dilation System

What is being measured

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

  1. Change in mean Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score

    Change from baseline to follow-up in the mean overall ETDQ-7 score. The ETDQ-7 is a validated 7-item patient-reported questionnaire reporting the presence and severity of symptoms associated with Eustachian tube dysfunction. Each item is scored from 1 (normal) to 7 (severe). The overall score is the mean score of the 7 items.

    Measured: 6 Months

  2. Complication rate

    Percentage of participants who experience 1 or more serious adverse events that are related to the device and/or procedure.

    Measured: 6 Months

Secondary outcomes (10)

  1. Procedural information

    Details of the balloon dilation procedure, including setting, anesthesia, technical success, concomitant procedures, procedure/device-related adverse events, and recovery time.

    Measured: Procedure through 6-week follow-up

  2. Minimal clinically important difference in ETDQ-7 score

    Percentage of participants achieving the minimal clinical important difference in overall ETDQ-7 score (reduction from baseline of 0.5 points or more). The ETDQ-7 is a validated 7-item patient-reported questionnaire reporting the presence and severity of symptoms associated with Eustachian tube dysfunction. Each item is scored from 1 (normal) to 7 (severe). The overall score is the mean score of the 7 items.

    Measured: 6 Months

  3. Revision Eustachian tube dilation

    Percentage of participants who require revision dilation on an ear that was treated in the initial procedure.

    Measured: 6 Months

  4. Surgical interventions

    Percentage of participants requiring surgical ear intervention (other than balloon dilation) on an ear that was treated in the initial procedure but has recurrent or continuing ETD symptoms.

    Measured: 6 Months

  5. Participant satisfaction: Proportion of participants indicating satisfaction and willing to recommend the procedure to friends or family

    Percentage of participants indicating satisfaction and willing to recommend the procedure to friends or family.

    Measured: 6 Months

  6. Change in work productivity/activity impairment

    Participants complete the validated Work Productivity and Activity Impairment (WPAI) at baseline and 6 month follow-up. The questionnaire consists of 6 questions that evaluate absenteeism, presenteeism, work productivity loss, and activity impairment over the previous week. Results are expressed as the percentage of impairment from 0 to 100, for which higher numbers indicate worse outcomes (ie, greater impairment and less productivity). Absenteeism is calculated by dividing the number of hours missed by the sum of the numbers of hours missed plus the number of hours worked. Presenteeism, is calculated by dividing the response to productivity at work question by 10, while activity impairment is calculated by dividing the response to the ability to carry out daily activities question by 10. Finally, the overall work impairment/productivity loss is calculated as the sum of absenteeism and the product of presenteeism and time at work.

    Measured: 6 Months

  7. Change from baseline in chronic rhinosinusitis symptoms

    Participants will complete the validated 22-item SinoNasal Outcomes Test (SNOT-22) to evaluate change in chronic rhinosinusitis symptoms. Each of the 22 symptoms on the questionnaire are rated by the participant from 0 (no problem) to 5 (bad). A sum of the 22 item scores provides the overall score, which can range from 0 to 110.

    Measured: 6 Months

  8. Improvement in tympanogram

    Percentage of participants with an abnormal tympanogram (type B or C) at baseline who have a normal (type A) or improved (type B to type C) tympanogram at follow-up.

    Measured: 6 Months

  9. Improvement in ability to perform a Valsalva maneuver

    Percentage of participants unable to perform the Valsalva maneuver (negative) at baseline who are able to perform the maneuver (positive) at follow-up.

    Measured: 6 Months

  10. Improvement in tympanic membrane position

    Percentage of participants with a retracted tympanic membrane at baseline who have a normal tympanic membrane position at follow-up.

    Measured: 6 Months

Timeline

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

  1. First posted23 Oct 2019
  2. Study start5 Jun 2018
  3. Primary completion28 Aug 2020
  4. Study completion28 Aug 2020

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
169 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04136977
Sponsor's protocol ID
4079-001
Status last verified
Sep 2020
First submitted
2 Oct 2019
Last updated
30 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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?

An observational study of Eustachian Tube Dysfunction, run by Entellus Medical, Inc. at 11 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 6 inclusion and 4 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 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 in mean Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score (time frame: 6 Months). 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 NCT04136977, which also lists 1 linked publication.

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 30 Sep 2020.

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