XprESS Eustachian Tube Dilation Study

Completed · Not applicable

Conditions studied: Eustachian Tube Dysfunction

In brief

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

Key facts

Study ID

NCT02391584

Run by

Entellus Medical, Inc.

People needed

60

Starts

2015-02-01

Expected to finish

2017-10-01

Last updated by the study team

2018-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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

You may not qualify if…

• 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

Where it is running

• Colorado Sinus Institute — Denver, Colorado, United States
• Ear Nose Throat and Sinus Clinic — North Platte, Nebraska, United States
• Donald Guthrie Foundation — Sayre, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Austin Ear Clinic — Austin, Texas, United States

Full record on ClinicalTrials.gov

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