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Study to assess the safety and efficacy of the XprESS device for transnasal Eustachian tube dilation.
Prospective, multicenter, randomized controlled trial comparing balloon dilation of the Eustachian tube to continued medical management for treatment of persistent Eustachian tube dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XprESS | Experimental | Balloon dilation of the Eustachian tube |
|
| Control | Other | Continued medical management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XprESS | Device | Balloon dilation of the Eustachian tube |
| |
| Control |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks post procedure (treatment arm) or randomization (control arm) |
| Complication Rate | Number of subjects who experience serious device- or procedure-related adverse events | Through 6 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success Rate | Percent of successful ET dilations per attempted ET dilations | Immediately after procedure |
| Revision Rate | Percent of participants undergoing repeat balloon dilation procedure on an ET that was initially treated with an XprESS device |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Sinus Institute | Denver | Colorado | 80210 | United States | ||
| Ear Nose Throat and Sinus Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29912819 | Result | 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. | |
| 40008607 |
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| ID | Title | Description |
|---|---|---|
| FG000 | XprESS | Balloon dilation of the Eustachian tube XprESS: Balloon dilation of the Eustachian tube |
| FG001 | Control | Continued medical management Control: Continued medical management |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary Endpoint (6-weeks) |
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| 3 Month |
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| 6 Month |
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| 12 Month (End of Study) |
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| ID | Title | Description |
|---|---|---|
| BG000 | XprESS | Balloon dilation of the Eustachian tube XprESS: Balloon dilation of the Eustachian tube |
| BG001 | Control | Continued medical management Control: Continued medical management |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All randomized participants with completed ETDQ-7 questionnaire at 6-week follow-up | Posted | Mean | Standard Deviation | units on a scale | 6 weeks post procedure (treatment arm) or randomization (control arm) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | XprESS Randomized Arm at 6 Weeks | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis/sinus infection | Infections and infestations | Standard terminology | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs Manager | Entellus Medical | 7634631595 | rschacherer@entellusmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2015 | Jun 27, 2018 | Prot_SAP_000.pdf |
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| Other |
Continued medical management |
|
|
| 12 months |
| 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. | 12 months postdilation |
| 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. | 6 months postdilation |
| 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. | 3 months postdilation |
| 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. | 6 weeks postdilation |
| North Platte |
| Nebraska |
| 69101 |
| United States |
| Donald Guthrie Foundation | Sayre | Pennsylvania | 18840 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Austin Ear Clinic | Austin | Texas | 78758 | United States |
| Swords C, Smith ME, Patel A, Norman G, Llewellyn A, Tysome JR. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025 Feb 26;2(2):CD013429. doi: 10.1002/14651858.CD013429.pub2. |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Duration of ETD (years) | Mean | Standard Deviation | years |
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| Baseline mean 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 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 | Standard Deviation | units on a scale |
|
Balloon dilation of the Eustachian tube XprESS: Balloon dilation of the Eustachian tube |
| OG001 | Control | Continued medical management Control: Continued medical management |
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| Primary | Complication Rate | Number of subjects who experience serious device- or procedure-related adverse events | All participant's randomized to balloon dilation who underwent the procedure and all control participant's with 6-week follow-up. | Posted | Count of Participants | Participants | Through 6 months post-procedure |
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| Secondary | Technical Success Rate | Percent of successful ET dilations per attempted ET dilations | All participants who underwent an attempted unilateral or bilateral balloon dilation of the ET. | Posted | Number | percentage of successful dilations | Immediately after procedure | ears | ears |
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| Secondary | Revision Rate | Percent of participants undergoing repeat balloon dilation procedure on an ET that was initially treated with an XprESS device | All participants who underwent balloon dilation (randomized and crossover). | Posted | Count of Participants | Participants | 12 months |
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| 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. | All balloon dilation participants (randomized and crossover) who completed an ETDQ-7 questionnaire at 12-month follow-up. | Posted | Least Squares Mean | Standard Deviation | units on a scale | 12 months postdilation |
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| 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. | All balloon dilation participants (randomized and crossover) who completed an ETDQ-7 questionnaire at 6-month follow-up. | Posted | Least Squares Mean | Standard Deviation | units on a scale | 6 months postdilation |
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| 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. | All balloon dilation participants (randomized and crossover) who completed an ETDQ-7 questionnaire at 3-month follow-up. | Posted | Least Squares Mean | Standard Deviation | units on a scale | 3 months postdilation |
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| 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. | All balloon dilation participants (randomized and crossover) who completed an ETDQ-7 questionnaire at 6-week follow-up. | Posted | Least Squares Mean | Standard Deviation | units on a scale | 6 weeks postdilation |
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| 0 |
| 30 |
| 0 |
| 30 |
| 2 |
| 30 |
| EG001 | Control Randomized Arm at 6 Weeks | 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. | 0 | 27 | 0 | 27 | 1 | 27 |
| EG002 | All Participants Through 12 Months | 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. | 0 | 57 | 0 | 57 | 13 | 57 |
| Ear infection | Ear and labyrinth disorders | Standard terminology | Systematic Assessment |
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| Cold/upper respiratory infection | Infections and infestations | Standard terminology | Systematic Assessment |
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