XprESS Eustachian Tube Dilation Study

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

Study Overview

• Status: Completed
• Conditions: Eustachian Tube Dysfunction
• Intervention / Treatment: Device: XprESS; Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80210
      • Colorado Sinus Institute
  • Nebraska
    • North Platte, Nebraska, United States, 69101
      • Ear Nose Throat and Sinus Clinic
  • Pennsylvania
    • Sayre, Pennsylvania, United States, 18840
      • Donald Guthrie Foundation
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Austin, Texas, United States, 78758
      • Austin Ear Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XprESS; Balloon dilation of the Eustachian tube	Device: XprESS; Balloon dilation of the Eustachian tube
Other: Control; Continued medical management	Other: Control; Continued medical management; Other Names: Continued medical management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks post procedure (treatment arm) or randomization (control arm)
Complication Rate	Number of subjects who experience serious device- or procedure-related adverse events	Through 6 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success Rate	Percent of successful ET dilations per attempted ET dilations	Immediately after procedure
Revision Rate	Percent of participants undergoing repeat balloon dilation procedure on an ET that was initially treated with an XprESS device	12 months
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.	12 months postdilation
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.	6 months postdilation
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.	3 months postdilation
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.	6 weeks postdilation

Collaborators and Investigators

• Sponsor: Entellus Medical, Inc.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: March 9, 2015
• First Submitted That Met QC Criteria: March 12, 2015
• First Posted (Estimate): March 18, 2015

Study Record Updates

• Last Update Posted (Actual): November 1, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: 2909-001

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