Clinical trial NCT04136977: XprESS ET Registry
Official title: XprESS Eustachian Tube Balloon Dilation Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eustachian Tube Dysfunction
Lead sponsor: Entellus Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: North American Science Associates Ltd.
First posted: 2019-10-23
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with persistent/chronic Eustachian tube dysfunction who are undergoing balloon dilation of the Eustachian tubes.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in mean Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score
timeFrame: 6 Months
measure: Complication rate
timeFrame: 6 Months
Secondary outcomes:
measure: Procedural information
timeFrame: Procedure through 6-week follow-up
measure: Minimal clinically important difference in ETDQ-7 score
timeFrame: 6 Months
measure: Revision Eustachian tube dilation
timeFrame: 6 Months
measure: Surgical interventions
timeFrame: 6 Months
measure: Participant satisfaction: Proportion of participants indicating satisfaction and willing to recommend the procedure to friends or family
timeFrame: 6 Months
measure: Change in work productivity/activity impairment
timeFrame: 6 Months
measure: Change from baseline in chronic rhinosinusitis symptoms
timeFrame: 6 Months
measure: Improvement in tympanogram
timeFrame: 6 Months
measure: Improvement in ability to perform a Valsalva maneuver
timeFrame: 6 Months
measure: Improvement in tympanic membrane position
timeFrame: 6 Months
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Breathe Clear Institute
state: California
city: Colorado Springs
country: United States
facility: Colorado ENT and Allergy
state: Colorado
city: Evans
country: United States
facility: Augusta ENT and Allergy
state: Georgia
city: Anderson
country: United States
facility: St. Vincent Anderson Hospital
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Southfield
country: United States
facility: Ear Nose and Throat Consultants
state: Michigan
city: Saint Cloud
country: United States
facility: St Cloud ENT
state: Minnesota
city: Las Vegas
country: United States
facility: ENT Consultants of Nevada
state: Nevada
city: Canandaigua
country: United States
facility: Lakeside ENT
state: New York
city: Charleston
country: United States
facility: National Allergy and ENT
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Ochsner Health System, New Orleans, LA
name: Edward D McCoul, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: