XprESS ET Registry

September 29, 2020 updated by: Entellus Medical, Inc.

XprESS Eustachian Tube Balloon Dilation Registry

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
169

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Torrance, California, United States, 90503
        • Breathe Clear Institute
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Colorado ENT and Allergy
    • Georgia
      • Evans, Georgia, United States, 30809
        • Augusta ENT and Allergy
    • Indiana
      • Anderson, Indiana, United States, 46016
        • St. Vincent Anderson Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Michigan
      • Southfield, Michigan, United States, 48934
        • Ear Nose and Throat Consultants
    • Minnesota
      • Saint Cloud, Minnesota, United States, 56303
        • St Cloud ENT
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • ENT Consultants of Nevada
    • New York
      • Canandaigua, New York, United States, 14424
        • Lakeside ENT
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Charleston, South Carolina, United States, 29420
        • National Allergy and ENT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in mean Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score
Time Frame: 6 Months
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.
6 Months
Complication rate
Time Frame: 6 Months
Percentage of participants who experience 1 or more serious adverse events that are related to the device and/or procedure.
6 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedural information
Time Frame: Procedure through 6-week follow-up
Details of the balloon dilation procedure, including setting, anesthesia, technical success, concomitant procedures, procedure/device-related adverse events, and recovery time.
Procedure through 6-week follow-up
Minimal clinically important difference in ETDQ-7 score
Time Frame: 6 Months
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.
6 Months
Revision Eustachian tube dilation
Time Frame: 6 Months
Percentage of participants who require revision dilation on an ear that was treated in the initial procedure.
6 Months
Surgical interventions
Time Frame: 6 Months
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.
6 Months
Participant satisfaction: Proportion of participants indicating satisfaction and willing to recommend the procedure to friends or family
Time Frame: 6 Months
Percentage of participants indicating satisfaction and willing to recommend the procedure to friends or family.
6 Months
Change in work productivity/activity impairment
Time Frame: 6 Months
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.
6 Months
Change from baseline in chronic rhinosinusitis symptoms
Time Frame: 6 Months
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.
6 Months
Improvement in tympanogram
Time Frame: 6 Months
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.
6 Months
Improvement in ability to perform a Valsalva maneuver
Time Frame: 6 Months
Percentage of participants unable to perform the Valsalva maneuver (negative) at baseline who are able to perform the maneuver (positive) at follow-up.
6 Months
Improvement in tympanic membrane position
Time Frame: 6 Months
Percentage of participants with a retracted tympanic membrane at baseline who have a normal tympanic membrane position at follow-up.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Entellus Medical, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
North American Science Associates Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Edward D McCoul, MD, PhD, Ochsner Health System, New Orleans, LA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 28, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4079-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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