Back to resultsXprESS Eustachian Tube Dilation Study
Primary Purpose
Eustachian Tube Dysfunction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
XprESS
Control
Sponsored by
About this trial
This is an interventional treatment trial for Eustachian Tube Dysfunction
Eligibility Criteria
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
Sites / Locations
- Colorado Sinus Institute
- Ear Nose Throat and Sinus Clinic
- Donald Guthrie Foundation
- Medical University of South Carolina
- Austin Ear Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
XprESS
Control
Arm Description
Balloon dilation of the Eustachian tube
Continued medical management
Outcomes
Primary Outcome Measures
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.
Complication Rate
Number of subjects who experience serious device- or procedure-related adverse events
Secondary Outcome Measures
Technical Success Rate
Percent of successful ET dilations per attempted ET dilations
Revision Rate
Percent of participants undergoing repeat balloon dilation procedure on an ET that was initially treated with an XprESS device
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02391584
Brief Title
XprESS Eustachian Tube Dilation Study
Official Title
XprESS Eustachian Tube Dilation Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Entellus Medical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study to assess the safety and efficacy of the XprESS device for transnasal Eustachian tube dilation.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eustachian Tube Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XprESS
Arm Type
Experimental
Arm Description
Balloon dilation of the Eustachian tube
Arm Title
Control
Arm Type
Other
Arm Description
Continued medical management
Intervention Type
Device
Intervention Name(s)
XprESS
Intervention Description
Balloon dilation of the Eustachian tube
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Continued medical management
Intervention Description
Continued medical management
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Overall ETDQ-7 Scores
Description
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.
Time Frame
6 weeks post procedure (treatment arm) or randomization (control arm)
Title
Complication Rate
Description
Number of subjects who experience serious device- or procedure-related adverse events
Time Frame
Through 6 months post-procedure
Secondary Outcome Measure Information:
Title
Technical Success Rate
Description
Percent of successful ET dilations per attempted ET dilations
Time Frame
Immediately after procedure
Title
Revision Rate
Description
Percent of participants undergoing repeat balloon dilation procedure on an ET that was initially treated with an XprESS device
Time Frame
12 months
Title
Mean Change in Overall ETDQ-7 Score
Description
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.
Time Frame
12 months postdilation
Title
Mean Change in Overall ETDQ-7 Score
Description
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.
Time Frame
6 months postdilation
Title
Mean Change in Overall ETDQ-7 Score
Description
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.
Time Frame
3 months postdilation
Title
Mean Change in Overall ETDQ-7 Score
Description
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.
Time Frame
6 weeks postdilation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Colorado Sinus Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Ear Nose Throat and Sinus Clinic
City
North Platte
State/Province
Nebraska
ZIP/Postal Code
69101
Country
United States
Facility Name
Donald Guthrie Foundation
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Austin Ear Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29912819
Citation
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.
Results Reference
result
Learn more about this trial
XprESS Eustachian Tube Dilation Study
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