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XprESS Eustachian Tube Dilation Study | Clinical Trials | Clareo Health

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COMPLETEDNANCT02391584

XprESS Eustachian Tube Dilation Study

Study to assess the safety and efficacy of the XprESS device for transnasal Eustachian tube dilation.

Lead sponsor: Entellus Medical, Inc.•5 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Entellus Medical, Inc.

Prospective, multicenter, randomized controlled trial comparing balloon dilation of the Eustachian tube to continued medical management for treatment of persistent Eustachian tube dysfunction.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•≥18 years old
•Have been diagnosed with symptoms of chronic Eustachian tube dysfunction for no less than 12 months prior to enrollment
•Have an overall ETDQ-7 score ≥3.0
•Have record of failed medical management for Eustachian tube dysfunction

Exclusion Criteria

•Require concomitant procedures at the time of the study enrollment or procedure
•Have patulous Eustachian tube
•Have ear tubes in place or perforation of the tympanic membrane
•Have evidence of internal carotid artery dehiscence
•Be pregnant at the time of enrollment
•Be currently participating in other drug or device studies

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 1, 2018Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment60

Start dateFeb 2015

Last updatedNov 1, 2018

Condition

Eustachian Tube Dysfunction

Locations shown

Colorado Sinus Institute

Denver, Colorado

Ear Nose Throat and Sinus Clinic

North Platte, Nebraska

Donald Guthrie Foundation

Sayre, Pennsylvania

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 1, 2018Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions