XprESS ET Registry

Eustachian Tube Dysfunction Clinical Trial

Official title:

XprESS Eustachian Tube Balloon Dilation Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04136977
• Other study ID #: 4079-001
• Status: Completed
• Start date: June 5, 2018
• Est. completion date: August 28, 2020

Study information

• Verified date: September 2020
• Source: Entellus Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

A prospective, multicenter, registry of patients undergoing balloon dilation of the Eustachian tubes (ET).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: August 28, 2020
• Est. primary completion date: August 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eustachian Tube Dysfunction

Intervention

Device:
• Eustachian tube dilation
Unilateral or bilateral balloon dilation of the Eustachian tube using the FDA-cleared XprESS ENT Dilation System

Locations

Country	Name	City	State
United States	St. Vincent Anderson Hospital	Anderson	Indiana
United States	Lakeside ENT	Canandaigua	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	National Allergy and ENT	Charleston	South Carolina
United States	Colorado ENT and Allergy	Colorado Springs	Colorado
United States	Augusta ENT and Allergy	Evans	Georgia
United States	ENT Consultants of Nevada	Las Vegas	Nevada
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	St Cloud ENT	Saint Cloud	Minnesota
United States	Ear Nose and Throat Consultants	Southfield	Michigan
United States	Breathe Clear Institute	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Entellus Medical, Inc.	North American Science Associates (NAMSA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 Months
Primary	Complication rate	Percentage of participants who experience 1 or more serious adverse events that are related to the device and/or procedure.	6 Months
Secondary	Procedural information	Details of the balloon dilation procedure, including setting, anesthesia, technical success, concomitant procedures, procedure/device-related adverse events, and recovery time.	Procedure through 6-week follow-up
Secondary	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.	6 Months
Secondary	Revision Eustachian tube dilation	Percentage of participants who require revision dilation on an ear that was treated in the initial procedure.	6 Months
Secondary	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.	6 Months
Secondary	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.	6 Months
Secondary	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.	6 Months
Secondary	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.	6 Months
Secondary	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.	6 Months
Secondary	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.	6 Months
Secondary	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.	6 Months