XprESS Eustachian Tube Dilation Study

• Sponsor: Entellus Medical, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02391584
• Collaborator: (none)
• Enrollment: 60
• Locations: 5
• Arms: 2
• Duration (Months): 32
• Patients Per Site: 12
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Eustachian Tube Dysfunction	Device: XprESS; Other: Control	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: XprESS Eustachian Tube Dilation Study
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Oct 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. Complication Rate [Through 6 months post-procedure]

   Number of subjects who experience serious device- or procedure-related adverse events

Secondary Outcome Measures

1. Technical Success Rate [Immediately after procedure]

   Percent of successful ET dilations per attempted ET dilations

2. Revision Rate [12 months]

   Percent of participants undergoing repeat balloon dilation procedure on an ET that was initially treated with an XprESS device

3. 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.

4. Mean Change in Overall ETDQ-7 Score [6 months postdilation]

   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.

5. Mean Change in Overall ETDQ-7 Score [3 months postdilation]

   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.

6. Mean Change in Overall ETDQ-7 Score [6 weeks postdilation]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Colorado Sinus Institute	Denver	Colorado	United States	80210
2	Ear Nose Throat and Sinus Clinic	North Platte	Nebraska	United States	69101
3	Donald Guthrie Foundation	Sayre	Pennsylvania	United States	18840
4	Medical University of South Carolina	Charleston	South Carolina	United States	29425
5	Austin Ear Clinic	Austin	Texas	United States	78758

Sponsors and Collaborators

• Entellus Medical, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 15, 2015

More Information

Publications

None provided.

• Responsible Party: Entellus Medical, Inc.
• ClinicalTrials.gov Identifier: NCT02391584
• Other Study ID Numbers: 2909-001
• First Posted: Mar 18, 2015
• Last Update Posted: Nov 1, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Dilatation, Pathologic

Study Results

Participant Flow

Arm/Group Title	XprESS	Control
Arm/Group Description	Balloon dilation of the Eustachian tube XprESS: Balloon dilation of the Eustachian tube	Continued medical management Control: Continued medical management
Period Title: Primary Endpoint (6-weeks)
STARTED	31	29
COMPLETED	29	27
NOT COMPLETED	2	2
Period Title: Primary Endpoint (6-weeks)
STARTED	53	0
COMPLETED	52	0
NOT COMPLETED	1	0
Period Title: Primary Endpoint (6-weeks)
STARTED	52	0
COMPLETED	51	0
NOT COMPLETED	1	0
Period Title: Primary Endpoint (6-weeks)
STARTED	51	0
COMPLETED	49	0
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	XprESS	Control	Total
Arm/Group Description	Balloon dilation of the Eustachian tube XprESS: Balloon dilation of the Eustachian tube	Continued medical management Control: Continued medical management	Total of all reporting groups
Overall Participants	31	29	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.0 (15.4)	46.6 (15.7)	49.4 (15.6)
Sex: Female, Male (Count of Participants)
Female	17 54.8%	14 48.3%	31 51.7%
Male	14 45.2%	15 51.7%	29 48.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	28 90.3%	26 89.7%	54 90%
More than one race	3 9.7%	3 10.3%	6 10%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	31 100%	29 100%	60 100%
Duration of ETD (years) (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	12.2 (17.0)	13.0 (17.3)	12.6 (17.0)
Baseline mean overall ETDQ-7 score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.6 (1.1)	5.0 (0.8)	4.7 (0.9)

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

All randomized participants with completed ETDQ-7 questionnaire at 6-week follow-up

Arm/Group Title	XprESS	Control
Arm/Group Description	Balloon dilation of the Eustachian tube XprESS: Balloon dilation of the Eustachian tube	Continued medical management Control: Continued medical management
Measure Participants	28	27
Mean (Standard Deviation) [units on a scale]	-2.9 (1.4)	-0.6 (1.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	XprESS, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	p<0.025 was considered significant.
	Method	t-test, 1 sided
	Comments

2. Primary Outcome

Title	Complication Rate
Description	Number of subjects who experience serious device- or procedure-related adverse events
Time Frame	Through 6 months post-procedure

Outcome Measure Data

Analysis Population Description

All participant's randomized to balloon dilation who underwent the procedure and all control participant's with 6-week follow-up.

Arm/Group Title	XprESS	Control
Arm/Group Description	Balloon dilation of the Eustachian tube XprESS: Balloon dilation of the Eustachian tube	Continued medical management Control: Continued medical management
Measure Participants	30	27
Count of Participants [Participants]	0 0%	0 0%

3. Secondary Outcome

Title	Technical Success Rate
Description	Percent of successful ET dilations per attempted ET dilations
Time Frame	Immediately after procedure

Outcome Measure Data

Analysis Population Description

All participants who underwent an attempted unilateral or bilateral balloon dilation of the ET.

Arm/Group Title	All Balloon Dilation Attempts
Arm/Group Description	All Eustachian tubes that underwent an attempted balloon dilation in participants who were randomized to balloon dilation or control participants who crossed over to balloon dilation.
Measure Participants	53
Measure ears	91
Number [percentage of successful dilations]	100

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants who underwent balloon dilation (randomized and crossover).

Arm/Group Title	All Balloon Dilation Participants
Arm/Group Description	Participants randomized and treated with balloon dilation and control participants who crossed over to balloon dilation.
Measure Participants	53
Count of Participants [Participants]	0 0%

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All balloon dilation participants (randomized and crossover) who completed an ETDQ-7 questionnaire at 12-month follow-up.

Arm/Group Title	All Balloon Dilation Participants
Arm/Group Description	Participants randomized and treated with balloon dilation and control participants who crossed over to balloon dilation.
Measure Participants	49
Least Squares Mean (Standard Deviation) [units on a scale]	-2.4 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	XprESS
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Dunnett's t-test was used for the multiple comparisons with baseline. A p value <0.05 was considered significant.
	Method	Mixed Models Analysis
	Comments

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All balloon dilation participants (randomized and crossover) who completed an ETDQ-7 questionnaire at 6-month follow-up.

Arm/Group Title	All Balloon Dilation Participants
Arm/Group Description	Participants randomized and treated with balloon dilation and control participants who crossed over to balloon dilation.
Measure Participants	51
Least Squares Mean (Standard Deviation) [units on a scale]	-2.4 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	XprESS
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Dunnett's t-test was used for the multiple comparisons with baseline. A p value <0.05 was considered significant.
	Method	Mixed Models Analysis
	Comments

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All balloon dilation participants (randomized and crossover) who completed an ETDQ-7 questionnaire at 3-month follow-up.

Arm/Group Title	All Balloon Dilation Participants
Arm/Group Description	Participants randomized and treated with balloon dilation and control participants who crossed over to balloon dilation.
Measure Participants	52
Least Squares Mean (Standard Deviation) [units on a scale]	-2.5 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	XprESS
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Dunnett's t-test was used for the multiple comparisons with baseline. A p value <0.05 was considered significant.
	Method	Mixed Models Analysis
	Comments

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All balloon dilation participants (randomized and crossover) who completed an ETDQ-7 questionnaire at 6-week follow-up.

Arm/Group Title	All Balloon Dilation Participants
Arm/Group Description	Participants randomized and treated with balloon dilation and control participants who crossed over to balloon dilation.
Measure Participants	51
Least Squares Mean (Standard Deviation) [units on a scale]	-2.5 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	XprESS
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Dunnett's t-test was used for the multiple comparisons with baseline. A p value <0.05 was considered significant.
	Method	Mixed Models Analysis
	Comments

Adverse Events

Time Frame	1. 6 weeks between randomized arms (balloon dilation vs control), and 2. 12 months for all participants
Arm/Group Title	XprESS Randomized Arm at 6 Weeks		Control Randomized Arm at 6 Weeks		All Participants Through 12 Months
Arm/Group Description	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.		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 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.
All Cause Mortality
	XprESS Randomized Arm at 6 Weeks		Control Randomized Arm at 6 Weeks		All Participants Through 12 Months
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/27 (0%)		0/57 (0%)
Serious Adverse Events
	XprESS Randomized Arm at 6 Weeks		Control Randomized Arm at 6 Weeks		All Participants Through 12 Months
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/27 (0%)		0/57 (0%)
Other (Not Including Serious) Adverse Events
	XprESS Randomized Arm at 6 Weeks		Control Randomized Arm at 6 Weeks		All Participants Through 12 Months
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/30 (6.7%)		1/27 (3.7%)		13/57 (22.8%)
Ear and labyrinth disorders
Ear infection	0/30 (0%)	0	1/27 (3.7%)	1	6/57 (10.5%)	7
Infections and infestations
Sinusitis/sinus infection	2/30 (6.7%)	2	0/27 (0%)	0	5/57 (8.8%)	6
Cold/upper respiratory infection	0/30 (0%)	0	0/27 (0%)	0	3/57 (5.3%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.