Eustachian Tube Dysfunction
Conditions
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.
Interventions
DEVICEXprESS
Balloon dilation of the Eustachian tube
OTHERControl
Continued medical management
Sponsors
Entellus Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Overall ETDQ-7 Scores | 6 weeks post procedure (treatment arm) or randomization (control arm) | 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 | Through 6 months post-procedure | Number of subjects who experience serious device- or procedure-related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success Rate | Immediately after procedure | Percent of successful ET dilations per attempted ET dilations |
| Revision Rate | 12 months | 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 | 12 months postdilation | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| XprESS Balloon dilation of the Eustachian tube
XprESS: Balloon dilation of the Eustachian tube | 31 |
| Control Continued medical management
Control: Continued medical management | 29 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12 Month (End of Study) | Lost to Follow-up | 2 | 0 |
| 3 Month | Lost to Follow-up | 1 | 0 |
| 6 Month | Withdrawal by Subject | 1 | 0 |
| Primary Endpoint (6-weeks) | Lost to Follow-up | 1 | 2 |
| Primary Endpoint (6-weeks) | Missed primary endpoint visit | 1 | 0 |
Baseline characteristics
| Characteristic | XprESS | Control | Total |
|---|---|---|---|
| Age, Continuous | 52.0 years STANDARD_DEVIATION 15.4 | 46.6 years STANDARD_DEVIATION 15.7 | 49.4 years STANDARD_DEVIATION 15.6 |
| Baseline mean overall ETDQ-7 score | 4.6 units on a scale STANDARD_DEVIATION 1.1 | 5.0 units on a scale STANDARD_DEVIATION 0.8 | 4.7 units on a scale STANDARD_DEVIATION 0.9 |
| Duration of ETD (years) | 12.2 years STANDARD_DEVIATION 17 | 13.0 years STANDARD_DEVIATION 17.3 | 12.6 years STANDARD_DEVIATION 17 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 26 Participants | 54 Participants |
| Region of Enrollment United States | 31 participants | 29 participants | 60 participants |
| Sex: Female, Male Female | 17 Participants | 14 Participants | 31 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 27 | 0 / 57 |
| other Total, other adverse events | 2 / 30 | 1 / 27 | 13 / 57 |
| serious Total, serious adverse events | 0 / 30 | 0 / 27 | 0 / 57 |
Outcome results
Primary
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.
Time frame: 6 weeks post procedure (treatment arm) or randomization (control arm)
Population: All randomized participants with completed ETDQ-7 questionnaire at 6-week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XprESS | Change From Baseline in Mean Overall ETDQ-7 Scores | -2.9 units on a scale | Standard Deviation 1.4 |
| Control | Change From Baseline in Mean Overall ETDQ-7 Scores | -0.6 units on a scale | Standard Deviation 1 |
p-value: <0.0001t-test, 1 sided
Primary
Complication Rate
Number of subjects who experience serious device- or procedure-related adverse events
Time frame: Through 6 months post-procedure
Population: All participant's randomized to balloon dilation who underwent the procedure and all control participant's with 6-week follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XprESS | Complication Rate | 0 Participants |
| Control | Complication Rate | 0 Participants |
Secondary
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.
Time frame: 6 weeks postdilation
Population: All balloon dilation participants (randomized and crossover) who completed an ETDQ-7 questionnaire at 6-week follow-up.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| XprESS | Mean Change in Overall ETDQ-7 Score | -2.5 units on a scale | Standard Deviation 1.4 |
p-value: <0.0001Mixed Models Analysis
Secondary
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.
Time frame: 6 months postdilation
Population: All balloon dilation participants (randomized and crossover) who completed an ETDQ-7 questionnaire at 6-month follow-up.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| XprESS | Mean Change in Overall ETDQ-7 Score | -2.4 units on a scale | Standard Deviation 1.4 |
p-value: <0.0001Mixed Models Analysis
Secondary
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.
Time frame: 3 months postdilation
Population: All balloon dilation participants (randomized and crossover) who completed an ETDQ-7 questionnaire at 3-month follow-up.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| XprESS | Mean Change in Overall ETDQ-7 Score | -2.5 units on a scale | Standard Deviation 1.4 |
p-value: <0.0001Mixed Models Analysis
Secondary
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.
Time frame: 12 months postdilation
Population: All balloon dilation participants (randomized and crossover) who completed an ETDQ-7 questionnaire at 12-month follow-up.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| XprESS | Mean Change in Overall ETDQ-7 Score | -2.4 units on a scale | Standard Deviation 1.4 |
p-value: <0.0001Mixed Models Analysis
Secondary
Revision Rate
Percent of participants undergoing repeat balloon dilation procedure on an ET that was initially treated with an XprESS device
Time frame: 12 months
Population: All participants who underwent balloon dilation (randomized and crossover).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XprESS | Revision Rate | 0 Participants |
Secondary
Technical Success Rate
Percent of successful ET dilations per attempted ET dilations
Time frame: Immediately after procedure
Population: All participants who underwent an attempted unilateral or bilateral balloon dilation of the ET.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XprESS | Technical Success Rate | 100 percentage of successful dilations |