Trial Outcomes & Findings for XprESS Eustachian Tube Dilation Study (NCT NCT02391584)
NCT ID: NCT02391584
Last Updated: 2018-11-01
Results Overview
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.
COMPLETED
NA
60 participants
6 weeks post procedure (treatment arm) or randomization (control arm)
2018-11-01
Participant Flow
Participant milestones
| Measure |
XprESS
Balloon dilation of the Eustachian tube
XprESS: Balloon dilation of the Eustachian tube
|
Control
Continued medical management
Control: Continued medical management
|
|---|---|---|
|
Primary Endpoint (6-weeks)
STARTED
|
31
|
29
|
|
Primary Endpoint (6-weeks)
COMPLETED
|
29
|
27
|
|
Primary Endpoint (6-weeks)
NOT COMPLETED
|
2
|
2
|
|
3 Month
STARTED
|
53
|
0
|
|
3 Month
COMPLETED
|
52
|
0
|
|
3 Month
NOT COMPLETED
|
1
|
0
|
|
6 Month
STARTED
|
52
|
0
|
|
6 Month
COMPLETED
|
51
|
0
|
|
6 Month
NOT COMPLETED
|
1
|
0
|
|
12 Month (End of Study)
STARTED
|
51
|
0
|
|
12 Month (End of Study)
COMPLETED
|
49
|
0
|
|
12 Month (End of Study)
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
XprESS
Balloon dilation of the Eustachian tube
XprESS: Balloon dilation of the Eustachian tube
|
Control
Continued medical management
Control: Continued medical management
|
|---|---|---|
|
Primary Endpoint (6-weeks)
Lost to Follow-up
|
1
|
2
|
|
Primary Endpoint (6-weeks)
Missed primary endpoint visit
|
1
|
0
|
|
3 Month
Lost to Follow-up
|
1
|
0
|
|
6 Month
Withdrawal by Subject
|
1
|
0
|
|
12 Month (End of Study)
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
XprESS Eustachian Tube Dilation Study
Baseline characteristics by cohort
| Measure |
XprESS
n=31 Participants
Balloon dilation of the Eustachian tube
XprESS: Balloon dilation of the Eustachian tube
|
Control
n=29 Participants
Continued medical management
Control: Continued medical management
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
46.6 years
STANDARD_DEVIATION 15.7 • n=7 Participants
|
49.4 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
29 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Duration of ETD (years)
|
12.2 years
STANDARD_DEVIATION 17.0 • n=5 Participants
|
13.0 years
STANDARD_DEVIATION 17.3 • n=7 Participants
|
12.6 years
STANDARD_DEVIATION 17.0 • n=5 Participants
|
|
Baseline mean overall ETDQ-7 score
|
4.6 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 0.8 • n=7 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks post procedure (treatment arm) or randomization (control arm)Population: All randomized participants with completed ETDQ-7 questionnaire at 6-week follow-up
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.
Outcome measures
| Measure |
XprESS
n=28 Participants
Balloon dilation of the Eustachian tube
XprESS: Balloon dilation of the Eustachian tube
|
Control
n=27 Participants
Continued medical management
Control: Continued medical management
|
|---|---|---|
|
Change From Baseline in Mean Overall ETDQ-7 Scores
|
-2.9 units on a scale
Standard Deviation 1.4
|
-0.6 units on a scale
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: Through 6 months post-procedurePopulation: All participant's randomized to balloon dilation who underwent the procedure and all control participant's with 6-week follow-up.
Number of subjects who experience serious device- or procedure-related adverse events
Outcome measures
| Measure |
XprESS
n=30 Participants
Balloon dilation of the Eustachian tube
XprESS: Balloon dilation of the Eustachian tube
|
Control
n=27 Participants
Continued medical management
Control: Continued medical management
|
|---|---|---|
|
Complication Rate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immediately after procedurePopulation: All participants who underwent an attempted unilateral or bilateral balloon dilation of the ET.
Percent of successful ET dilations per attempted ET dilations
Outcome measures
| Measure |
XprESS
n=91 ears
Balloon dilation of the Eustachian tube
XprESS: Balloon dilation of the Eustachian tube
|
Control
Continued medical management
Control: Continued medical management
|
|---|---|---|
|
Technical Success Rate
|
100 percentage of successful dilations
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All participants who underwent balloon dilation (randomized and crossover).
Percent of participants undergoing repeat balloon dilation procedure on an ET that was initially treated with an XprESS device
Outcome measures
| Measure |
XprESS
n=53 Participants
Balloon dilation of the Eustachian tube
XprESS: Balloon dilation of the Eustachian tube
|
Control
Continued medical management
Control: Continued medical management
|
|---|---|---|
|
Revision Rate
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 months postdilationPopulation: All balloon dilation participants (randomized and crossover) who completed an ETDQ-7 questionnaire at 12-month follow-up.
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.
Outcome measures
| Measure |
XprESS
n=49 Participants
Balloon dilation of the Eustachian tube
XprESS: Balloon dilation of the Eustachian tube
|
Control
Continued medical management
Control: Continued medical management
|
|---|---|---|
|
Mean Change in Overall ETDQ-7 Score
|
-2.4 units on a scale
Standard Deviation 1.4
|
—
|
SECONDARY outcome
Timeframe: 6 months postdilationPopulation: All balloon dilation participants (randomized and crossover) who completed an ETDQ-7 questionnaire at 6-month follow-up.
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.
Outcome measures
| Measure |
XprESS
n=51 Participants
Balloon dilation of the Eustachian tube
XprESS: Balloon dilation of the Eustachian tube
|
Control
Continued medical management
Control: Continued medical management
|
|---|---|---|
|
Mean Change in Overall ETDQ-7 Score
|
-2.4 units on a scale
Standard Deviation 1.4
|
—
|
SECONDARY outcome
Timeframe: 3 months postdilationPopulation: All balloon dilation participants (randomized and crossover) who completed an ETDQ-7 questionnaire at 3-month follow-up.
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.
Outcome measures
| Measure |
XprESS
n=52 Participants
Balloon dilation of the Eustachian tube
XprESS: Balloon dilation of the Eustachian tube
|
Control
Continued medical management
Control: Continued medical management
|
|---|---|---|
|
Mean Change in Overall ETDQ-7 Score
|
-2.5 units on a scale
Standard Deviation 1.4
|
—
|
SECONDARY outcome
Timeframe: 6 weeks postdilationPopulation: All balloon dilation participants (randomized and crossover) who completed an ETDQ-7 questionnaire at 6-week follow-up.
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.
Outcome measures
| Measure |
XprESS
n=51 Participants
Balloon dilation of the Eustachian tube
XprESS: Balloon dilation of the Eustachian tube
|
Control
Continued medical management
Control: Continued medical management
|
|---|---|---|
|
Mean Change in Overall ETDQ-7 Score
|
-2.5 units on a scale
Standard Deviation 1.4
|
—
|
Adverse Events
XprESS Randomized Arm at 6 Weeks
Control Randomized Arm at 6 Weeks
All Participants Through 12 Months
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
XprESS Randomized Arm at 6 Weeks
n=30 participants at risk
All participants randomized to balloon dilation and followed through at least the 6-week visit. One randomized balloon dilation participant did not undergo procedure and did not return for the 6-week visit, so this participant is not included in the safety analysis. One other participant did not complete the ETDQ-7 for the primary efficacy endpoint but otherwise completed the rest of the 6-week visit and is therefore included in the safety analysis, resulting in a total XprESS safety population of 30.
|
Control Randomized Arm at 6 Weeks
n=27 participants at risk
All participants randomized to control and followed through at least the 6-week visit. Two randomized control participants did not return for the 6-week visit, so are not included in the safety analysis resulting in a total control population of 27 for the safety analysis. Control participants who did not crossover were exited from the study after the 6-week visit.
|
All Participants Through 12 Months
n=57 participants at risk
All participants who were followed through at least the 6-week visit. After the 6-week visit, control participants were either exited or crossed over the balloon dilation.
|
|---|---|---|---|
|
Infections and infestations
Sinusitis/sinus infection
|
6.7%
2/30 • Number of events 2 • 1. 6 weeks between randomized arms (balloon dilation vs control), and 2. 12 months for all participants
|
0.00%
0/27 • 1. 6 weeks between randomized arms (balloon dilation vs control), and 2. 12 months for all participants
|
8.8%
5/57 • Number of events 6 • 1. 6 weeks between randomized arms (balloon dilation vs control), and 2. 12 months for all participants
|
|
Ear and labyrinth disorders
Ear infection
|
0.00%
0/30 • 1. 6 weeks between randomized arms (balloon dilation vs control), and 2. 12 months for all participants
|
3.7%
1/27 • Number of events 1 • 1. 6 weeks between randomized arms (balloon dilation vs control), and 2. 12 months for all participants
|
10.5%
6/57 • Number of events 7 • 1. 6 weeks between randomized arms (balloon dilation vs control), and 2. 12 months for all participants
|
|
Infections and infestations
Cold/upper respiratory infection
|
0.00%
0/30 • 1. 6 weeks between randomized arms (balloon dilation vs control), and 2. 12 months for all participants
|
0.00%
0/27 • 1. 6 weeks between randomized arms (balloon dilation vs control), and 2. 12 months for all participants
|
5.3%
3/57 • Number of events 7 • 1. 6 weeks between randomized arms (balloon dilation vs control), and 2. 12 months for all participants
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60