Eustachian Tube Dysfunction
Conditions
Brief summary
A prospective, multicenter, registry of patients undergoing balloon dilation of the Eustachian tubes (ET).
Detailed description
This is a prospective, multicenter, single-arm, postmarket registry enrolling up to 300 participants who are planning to undergo balloon dilation of the Eustachian tubes for treatment of chronic/persistent Eustachian tube dysfunction (ETD). Procedural information will be collect as well as efficacy and safety data through 6 months post procedure.
Interventions
DEVICEEustachian tube dilation
Unilateral or bilateral balloon dilation of the Eustachian tube using the FDA-cleared XprESS ENT Dilation System
Sponsors
North American Science Associates Ltd.
Entellus Medical, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years old * Have been diagnosed with persistent/chronic Eustachian tube dysfunction (duration 3 months or more) * Be a candidate for unilateral or bilateral Eustachian tube balloon dilation using the XprESS device * Be able to read and understand English * Be willing and able to provide informed consent * Be willing to comply with the protocol requirements
Exclusion criteria
* Have a history of patulous Eustachian tube * Require additional ear surgery (eg, myringotomy, tympanostomy) at the time of study procedure * Have evidence of internal carotid artery dehiscence * Be currently participating in any other drug or device clinical studies, excluding postapproval or marketing registry studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score | 6 Months | Change from baseline to follow-up in the mean overall ETDQ-7 score. The ETDQ-7 is a validated 7-item patient-reported questionnaire reporting the presence and severity of symptoms associated with Eustachian tube dysfunction. Each item is scored from 1 (normal) to 7 (severe). The overall score is the mean score of the 7 items. |
| Complication rate | 6 Months | Percentage of participants who experience 1 or more serious adverse events that are related to the device and/or procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Revision Eustachian tube dilation | 6 Months | Percentage of participants who require revision dilation on an ear that was treated in the initial procedure. |
| Surgical interventions | 6 Months | Percentage of participants requiring surgical ear intervention (other than balloon dilation) on an ear that was treated in the initial procedure but has recurrent or continuing ETD symptoms. |
| Participant satisfaction: Proportion of participants indicating satisfaction and willing to recommend the procedure to friends or family | 6 Months | Percentage of participants indicating satisfaction and willing to recommend the procedure to friends or family. |
| Change in work productivity/activity impairment | 6 Months | Participants complete the validated Work Productivity and Activity Impairment (WPAI) at baseline and 6 month follow-up. The questionnaire consists of 6 questions that evaluate absenteeism, presenteeism, work productivity loss, and activity impairment over the previous week. Results are expressed as the percentage of impairment from 0 to 100, for which higher numbers indicate worse outcomes (ie, greater impairment and less productivity). Absenteeism is calculated by dividing the number of hours missed by the sum of the numbers of hours missed plus the number of hours worked. Presenteeism, is calculated by dividing the response to productivity at work question by 10, while activity impairment is calculated by dividing the response to the ability to carry out daily activities question by 10. Finally, the overall work impairment/productivity loss is calculated as the sum of absenteeism and the product of presenteeism and time at work. |
| Procedural information | Procedure through 6-week follow-up | Details of the balloon dilation procedure, including setting, anesthesia, technical success, concomitant procedures, procedure/device-related adverse events, and recovery time. |
| Improvement in tympanogram | 6 Months | Percentage of participants with an abnormal tympanogram (type B or C) at baseline who have a normal (type A) or improved (type B to type C) tympanogram at follow-up. |
| Improvement in ability to perform a Valsalva maneuver | 6 Months | Percentage of participants unable to perform the Valsalva maneuver (negative) at baseline who are able to perform the maneuver (positive) at follow-up. |
| Improvement in tympanic membrane position | 6 Months | Percentage of participants with a retracted tympanic membrane at baseline who have a normal tympanic membrane position at follow-up. |
| Change from baseline in chronic rhinosinusitis symptoms | 6 Months | Participants will complete the validated 22-item SinoNasal Outcomes Test (SNOT-22) to evaluate change in chronic rhinosinusitis symptoms. Each of the 22 symptoms on the questionnaire are rated by the participant from 0 (no problem) to 5 (bad). A sum of the 22 item scores provides the overall score, which can range from 0 to 110. |
| Minimal clinically important difference in ETDQ-7 score | 6 Months | Percentage of participants achieving the minimal clinical important difference in overall ETDQ-7 score (reduction from baseline of 0.5 points or more). The ETDQ-7 is a validated 7-item patient-reported questionnaire reporting the presence and severity of symptoms associated with Eustachian tube dysfunction. Each item is scored from 1 (normal) to 7 (severe). The overall score is the mean score of the 7 items. |
Countries
United States
Outcome results
None listed