This trial is active, not recruiting.

Condition eustachian tube dysfunction
Treatment xpress device
Sponsor Entellus Medical, Inc.
Start date February 2015
End date October 2016
Trial size 50 participants
Trial identifier NCT02391584, 2909-001


Study to asses safety and efficacy of XprESS device in transnasal Eustachian tube dilation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
XprESS balloon dilation device
xpress device
Balloon dilation

Primary Outcomes

Technical success rate
time frame: Through 3 months post-procedure
Complication rate
time frame: Through 3 months post-procedure

Eligibility Criteria

Male or female participants at least 18 years old.

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 record of failed medical management for Eustachian tube dysfunction Exclusion Criteria: - Have evidence of internal carotid artery dehiscence - Be pregnant at the time of enrollment - Be currently participating in other drug or device studies

Additional Information

Official title XprESS Eustachian Tube Dilation Study
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Entellus Medical, Inc..