XprESS Eustachian Tube Dilation Study

Entellus Medical

Status: Completed

Conditions: Eustachian Tube Dysfunction

Treatments: Device: XprESS; Other: Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT02391584

2909-001

Details and patient eligibility

About

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

Full description

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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

XprESS

Experimental group

Description:

Balloon dilation of the Eustachian tube

Treatment:

Device: XprESS

Control

Other group

Description:

Continued medical management

Treatment:

Other: Control