XprESS ET Registry

XprESS Eustachian Tube Balloon Dilation Registry

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

Study Overview

• Status: Completed
• Conditions: Eustachian Tube Dysfunction
• Intervention / Treatment: Device: Eustachian tube dilation

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: Observational
• Enrollment (Actual): 169

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 Months
Complication rate	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

Outcome Measure	Measure Description	Time Frame
Procedural information	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	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	Percentage of participants who require revision dilation on an ear that was treated in the initial procedure.	6 Months
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.	6 Months
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.	6 Months
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.	6 Months
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.	6 Months
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.	6 Months
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.	6 Months
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.	6 Months

Collaborators and Investigators

• Sponsor: Entellus Medical, Inc.
• Collaborators: North American Science Associates Ltd.
• Investigators: Principal Investigator: Edward D McCoul, MD, PhD, Ochsner Health System, New Orleans, LA

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 5, 2018
• Primary Completion (ACTUAL): August 28, 2020
• Study Completion (ACTUAL): August 28, 2020

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (ACTUAL): October 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 30, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID 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