Eustachian Tube Dysfunction
Conditions
Brief summary
The objective of this study is to determine whether Eustachian tube dilation in conjunction with medical management or medical management alone is effective for treating Eustachian tube dysfunction.
Interventions
DEVICEAcclarent Eustachian Tube Balloon Catheter (ETBC)
Sponsors
Acclarent
Integra LifeSciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult male or female aged 22 years and older * Persistent Eustachian tube dysfunction * Failure of medical management * Positive diagnosis of ETD * Absence of internal carotid artery (ICA) dehiscence * Able to read and understand English
Exclusion criteria
* Females who are pregnant or lactating * Anatomy that requires an adjunctive surgical procedure * Concomitant nasal or sinus procedures planned on the same day as surgical procedure * Concomitant ear procedures planned on the same day as surgical procedure * History of major surgery of the head or neck within four (4) months prior to surgery * History of patulous ET * History of fluctuating sensorineural hearing loss * Active acute otitis media * Tympanic membrane perforation * Tympanosclerosis * Acute upper respiratory infection * Temporomandibular joint disorder * Cleft palate * Craniofacial syndrome * Cystic fibrosis * Ciliary dysmotility syndrome * Systemic mucosal or immunodeficiency disease * Intolerance of medication for ETD * Prior intervention of Eustachian tube
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks | 6 Week Follow-Up Visit | The primary efficacy analysis compares randomized subjects with tympanogram normalization (Types B or C normalized to Type A) in all indicated ears at 6 weeks in the investigational arm versus the control arm. Per protocol, tympanogram types are defined as follows: Type A: Peak compliance occurs between +50 and -100 daPa, with minimum peak height of 0.2ml. Indicates NORMAL middle ear function Type B: No sharp peak and a rounded line. Indicates ABNORMAL middle ear function Type C: Peak compliance occurs beyond -100 daPa. Indicates ABNORMAL middle ear function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Efficacy Endpoint: Number of Randomized Subjects With MID Improvement From Baseline of 0.5 Points or More at 6 Weeks | 6 Week Follow-Up Visit | The secondary efficacy endpoint will consist of comparison of subjects achieving at least a minimally important difference (MID) level improvement of 0.5 points on the ETDQ-7 at 6 weeks post-treatment in the investigational arm versus the proportion of subjects achieving at least an MID level improvement on the ETDQ-7 at 6 weeks post-randomization in the control arm The ETDQ-7 is a seven-item ETD specific validated quality of life survey. A mean item score of greater or equal to 2.1 indicates the presence of ETD. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Endpoint: Number of Randomized Subjects With Normalized Tympanometry at 12.24,52 Weeks | 12, 24, 52 Week Follow-Up | Evaluation of subjects experiencing normalization of tympanometry at 12 weeks, 24 weeks, and 52 weeks post-treatment in the investigational arm and evaluation of subjects experiencing normalization of tympanometry at 12 weeks, 24 weeks, and 52 weeks post-randomization in the control arm. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits. |
| Exploratory Endpoint: Number of Randomized Subjects With ETDQ-7 Improvement at 12, 24, 52 Weeks | 12,24,52 Week Follow-Up Visit | Evaluation of subjects achieving at least a MID level improvement of 0.5 points at 12 weeks, 24 weeks, and 52 weeks post-treatment in the investigational arm and evaluation of subjects achieving at least a MID level improvement at 12 weeks, 24 weeks, and 52 weeks post-randomization in the control arm. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits. |
| Exploratory Endpoint: WPAI at 6,12,24,52 Weeks | 6,12,24,52 Week Follow-Up | Evaluation of subjects' work and activity impairment before and after treatment in both the investigational arm and the control arm. The Work Productivity and Activity Impairment (WPAI) questionnaire is a 6-question patient-reported general health assessment of productivity and activity impairment. WPAI results are expressed as the percentage of impairment from 0 to 100 where higher numbers indicate greater impairment or less productivity. Due to an error in the WPAI electronic data collection form, 2 questions were not visible to many subjects resulting in a significant amount of missing data for all scores except non-work activity impairment. Therefore, only the non-work activity impairment results are presented. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lead-In Subjects enrolled in Lead-In Group | 81 |
| Randomized ETBC Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM) | 162 |
| Randomized MM Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits | 80 |
| Total | 323 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 |
| Overall Study | F/U not completed w/in study window | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 6 | 13 | 7 |
| Overall Study | Other | 1 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 1 | 0 |
| Overall Study | Procedure not done | 1 | 13 | 0 |
| Overall Study | Pt moved out of town | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 5 | 3 |
Baseline characteristics
| Characteristic | Lead-In | Randomized ETBC | Randomized MM | Total |
|---|---|---|---|---|
| Age, Continuous | 53.7 Years STANDARD_DEVIATION 14.1 | 55.6 Years STANDARD_DEVIATION 14.3 | 57.7 Years STANDARD_DEVIATION 13.4 | 55.6 Years STANDARD_DEVIATION 14.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 9 Participants | 2 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 80 Participants | 153 Participants | 78 Participants | 311 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 12 Participants | 8 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) White | 77 Participants | 147 Participants | 67 Participants | 291 Participants |
| Sex: Female, Male Female | 30 Participants | 77 Participants | 48 Participants | 155 Participants |
| Sex: Female, Male Male | 51 Participants | 85 Participants | 32 Participants | 168 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 1 / 149 | 0 / 70 | 1 / 299 | 0 / 80 |
| other Total, other adverse events | 30 / 80 | 58 / 149 | 20 / 70 | 108 / 299 | 18 / 80 |
| serious Total, serious adverse events | 2 / 80 | 5 / 149 | 0 / 70 | 7 / 299 | 1 / 80 |
Outcome results
Primary
Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks
The primary efficacy analysis compares randomized subjects with tympanogram normalization (Types B or C normalized to Type A) in all indicated ears at 6 weeks in the investigational arm versus the control arm. Per protocol, tympanogram types are defined as follows: Type A: Peak compliance occurs between +50 and -100 daPa, with minimum peak height of 0.2ml. Indicates NORMAL middle ear function Type B: No sharp peak and a rounded line. Indicates ABNORMAL middle ear function Type C: Peak compliance occurs beyond -100 daPa. Indicates ABNORMAL middle ear function
Time frame: 6 Week Follow-Up Visit
Population: Primary Analysis Cohort (PAC): The PAC is defined as all randomized subjects who receive a study treatment for which they are randomized and have completed their primary analysis visits (i.e. completer analysis with baseline and 6 week tympanogram).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Randomized ETBC | Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks | 73 Participants |
| Randomized MM | Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks | 10 Participants |
Secondary
Secondary Efficacy Endpoint: Number of Randomized Subjects With MID Improvement From Baseline of 0.5 Points or More at 6 Weeks
The secondary efficacy endpoint will consist of comparison of subjects achieving at least a minimally important difference (MID) level improvement of 0.5 points on the ETDQ-7 at 6 weeks post-treatment in the investigational arm versus the proportion of subjects achieving at least an MID level improvement on the ETDQ-7 at 6 weeks post-randomization in the control arm The ETDQ-7 is a seven-item ETD specific validated quality of life survey. A mean item score of greater or equal to 2.1 indicates the presence of ETD.
Time frame: 6 Week Follow-Up Visit
Population: Primary Analysis Cohort (PAC): The PAC is defined as all randomized subjects who receive a study treatment for which they are randomized and have completed their primary analysis visits (i.e. completer analysis with baseline and 6 week tympanogram).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Randomized ETBC | Secondary Efficacy Endpoint: Number of Randomized Subjects With MID Improvement From Baseline of 0.5 Points or More at 6 Weeks | 128 Participants |
| Randomized MM | Secondary Efficacy Endpoint: Number of Randomized Subjects With MID Improvement From Baseline of 0.5 Points or More at 6 Weeks | 32 Participants |
Other Pre-specified
Exploratory Endpoint: Number of Randomized Subjects With ETDQ-7 Improvement at 12, 24, 52 Weeks
Evaluation of subjects achieving at least a MID level improvement of 0.5 points at 12 weeks, 24 weeks, and 52 weeks post-treatment in the investigational arm and evaluation of subjects achieving at least a MID level improvement at 12 weeks, 24 weeks, and 52 weeks post-randomization in the control arm. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.
Time frame: 12,24,52 Week Follow-Up Visit
Population: Per-Protocol Cohort: All randomized subjects expect those who: • Did not complete a baseline or respective follow-up assessment for the time point under analysis • Did not receive the treatment for which they were randomized • Had any major protocol deviation(s)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Randomized ETBC | Exploratory Endpoint: Number of Randomized Subjects With ETDQ-7 Improvement at 12, 24, 52 Weeks | 12 Week Visit | 118 Participants |
| Randomized ETBC | Exploratory Endpoint: Number of Randomized Subjects With ETDQ-7 Improvement at 12, 24, 52 Weeks | 24 Week Visit | 123 Participants |
| Randomized ETBC | Exploratory Endpoint: Number of Randomized Subjects With ETDQ-7 Improvement at 12, 24, 52 Weeks | 52 Week Visit | 111 Participants |
| Randomized MM | Exploratory Endpoint: Number of Randomized Subjects With ETDQ-7 Improvement at 12, 24, 52 Weeks | 24 Week Visit | 5 Participants |
| Randomized MM | Exploratory Endpoint: Number of Randomized Subjects With ETDQ-7 Improvement at 12, 24, 52 Weeks | 52 Week Visit | 3 Participants |
| Randomized MM | Exploratory Endpoint: Number of Randomized Subjects With ETDQ-7 Improvement at 12, 24, 52 Weeks | 12 Week Visit | 9 Participants |
Other Pre-specified
Exploratory Endpoint: Number of Randomized Subjects With Normalized Tympanometry at 12.24,52 Weeks
Evaluation of subjects experiencing normalization of tympanometry at 12 weeks, 24 weeks, and 52 weeks post-treatment in the investigational arm and evaluation of subjects experiencing normalization of tympanometry at 12 weeks, 24 weeks, and 52 weeks post-randomization in the control arm. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.
Time frame: 12, 24, 52 Week Follow-Up
Population: Per-Protocol Cohort: All randomized subjects expect those who: • Did not complete a baseline or respective follow-up assessment for the time point under analysis • Did not receive the treatment for which they were randomized • Had any major protocol deviation(s)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Randomized ETBC | Exploratory Endpoint: Number of Randomized Subjects With Normalized Tympanometry at 12.24,52 Weeks | 12 Week Visit | 64 Participants |
| Randomized ETBC | Exploratory Endpoint: Number of Randomized Subjects With Normalized Tympanometry at 12.24,52 Weeks | 24 Week Visit | 78 Participants |
| Randomized ETBC | Exploratory Endpoint: Number of Randomized Subjects With Normalized Tympanometry at 12.24,52 Weeks | 52 Week Visit | 71 Participants |
| Randomized MM | Exploratory Endpoint: Number of Randomized Subjects With Normalized Tympanometry at 12.24,52 Weeks | 12 Week Visit | 7 Participants |
| Randomized MM | Exploratory Endpoint: Number of Randomized Subjects With Normalized Tympanometry at 12.24,52 Weeks | 24 Week Visit | 5 Participants |
| Randomized MM | Exploratory Endpoint: Number of Randomized Subjects With Normalized Tympanometry at 12.24,52 Weeks | 52 Week Visit | 2 Participants |
Other Pre-specified
Exploratory Endpoint: WPAI at 6,12,24,52 Weeks
Evaluation of subjects' work and activity impairment before and after treatment in both the investigational arm and the control arm. The Work Productivity and Activity Impairment (WPAI) questionnaire is a 6-question patient-reported general health assessment of productivity and activity impairment. WPAI results are expressed as the percentage of impairment from 0 to 100 where higher numbers indicate greater impairment or less productivity. Due to an error in the WPAI electronic data collection form, 2 questions were not visible to many subjects resulting in a significant amount of missing data for all scores except non-work activity impairment. Therefore, only the non-work activity impairment results are presented. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.
Time frame: 6,12,24,52 Week Follow-Up
Population: Per-Protocol Cohort: All randomized subjects expect those who: • Did not complete a baseline or respective follow-up assessment for the time point under analysis • Did not receive the treatment for which they were randomized • Had any major protocol deviation(s)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized ETBC | Exploratory Endpoint: WPAI at 6,12,24,52 Weeks | 6 Week Visit | 16.6 Percentage of Impairment | Standard Deviation 23.6 |
| Randomized ETBC | Exploratory Endpoint: WPAI at 6,12,24,52 Weeks | 24 Week Visit | 12.0 Percentage of Impairment | Standard Deviation 19.5 |
| Randomized ETBC | Exploratory Endpoint: WPAI at 6,12,24,52 Weeks | 12 Week Visit | 10.9 Percentage of Impairment | Standard Deviation 16.1 |
| Randomized ETBC | Exploratory Endpoint: WPAI at 6,12,24,52 Weeks | 52 Week Visit | 9.1 Percentage of Impairment | Standard Deviation 18.2 |
| Randomized ETBC | Exploratory Endpoint: WPAI at 6,12,24,52 Weeks | Baseline | 45.3 Percentage of Impairment | Standard Deviation 32.8 |
| Randomized MM | Exploratory Endpoint: WPAI at 6,12,24,52 Weeks | 52 Week Visit | 17.5 Percentage of Impairment | Standard Deviation 20.6 |
| Randomized MM | Exploratory Endpoint: WPAI at 6,12,24,52 Weeks | Baseline | 50.4 Percentage of Impairment | Standard Deviation 31.1 |
| Randomized MM | Exploratory Endpoint: WPAI at 6,12,24,52 Weeks | 6 Week Visit | 47.1 Percentage of Impairment | Standard Deviation 32 |
| Randomized MM | Exploratory Endpoint: WPAI at 6,12,24,52 Weeks | 12 Week Visit | 38.2 Percentage of Impairment | Standard Deviation 27.5 |
| Randomized MM | Exploratory Endpoint: WPAI at 6,12,24,52 Weeks | 24 Week Visit | 33.8 Percentage of Impairment | Standard Deviation 37 |