XprESS ET Registry

Completed

Conditions studied: Eustachian Tube Dysfunction

In brief

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

Key facts

Study ID

NCT04136977

Run by

Entellus Medical, Inc.

People needed

169

Starts

2018-06-05

Expected to finish

2020-08-28

Last updated by the study team

2020-09-30

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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