A prospective, multicenter, registry of patients undergoing balloon dilation of the Eustachian tubes (ET).
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.
Study Type
OBSERVATIONAL
Enrollment
169
Unilateral or bilateral balloon dilation of the Eustachian tube using the FDA-cleared XprESS ENT Dilation System
Breathe Clear Institute
Torrance, California, United States
Colorado ENT and Allergy
Colorado Springs, Colorado, United States
Augusta ENT and Allergy
Evans, Georgia, United States
Change in mean Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score
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.
Time frame: 6 Months
Complication rate
Percentage of participants who experience 1 or more serious adverse events that are related to the device and/or procedure.
Time frame: 6 Months
Procedural information
Details of the balloon dilation procedure, including setting, anesthesia, technical success, concomitant procedures, procedure/device-related adverse events, and recovery time.
Time frame: Procedure through 6-week follow-up
Minimal clinically important difference in ETDQ-7 score
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.
Time frame: 6 Months
Revision Eustachian tube dilation
Percentage of participants who require revision dilation on an ear that was treated in the initial procedure.
Time frame: 6 Months
Surgical interventions
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.
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St. Vincent Anderson Hospital
Anderson, Indiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Ear Nose and Throat Consultants
Southfield, Michigan, United States
St Cloud ENT
Saint Cloud, Minnesota, United States
ENT Consultants of Nevada
Las Vegas, Nevada, United States
Lakeside ENT
Canandaigua, New York, United States
National Allergy and ENT
Charleston, South Carolina, United States
...and 1 more locations
Time frame: 6 Months
Participant satisfaction: Proportion of participants indicating satisfaction and willing to recommend the procedure to friends or family
Percentage of participants indicating satisfaction and willing to recommend the procedure to friends or family.
Time frame: 6 Months
Change in work productivity/activity impairment
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.
Time frame: 6 Months
Change from baseline in chronic rhinosinusitis symptoms
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.
Time frame: 6 Months
Improvement in tympanogram
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.
Time frame: 6 Months
Improvement in ability to perform a Valsalva maneuver
Percentage of participants unable to perform the Valsalva maneuver (negative) at baseline who are able to perform the maneuver (positive) at follow-up.
Time frame: 6 Months
Improvement in tympanic membrane position
Percentage of participants with a retracted tympanic membrane at baseline who have a normal tympanic membrane position at follow-up.
Time frame: 6 Months