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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04136977
Other study ID # 4079-001
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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