XprESS ET Registry

Entellus Medical

Status: Completed

Conditions: Eustachian Tube Dysfunction

Treatments: Device: Eustachian tube dilation

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT04136977

4079-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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