Overview

This trial is active, not recruiting.

Condition eustachian tube dysfunction
Treatments xpress, control
Sponsor Entellus Medical, Inc.
Start date February 2015
End date March 2017
Trial size 70 participants
Trial identifier NCT02391584, 2909-001

Summary

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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Balloon dilation of the Eustachian tube
xpress
Balloon dilation of the Eustachian tube
(Other)
Continued medical management
control
Continued current medical management

Primary Outcomes

Measure
Overall change in ETDQ-7 scores from baseline
time frame: 6 weeks post procedure (treatment arm) or randomization (control arm)
Complication rate
time frame: Through 6 months post-procedure

Secondary Outcomes

Measure
Technical success rate
time frame: Immediately after procedure
Revision rate
time frame: 12 months
Mean change in overall ETDQ-7 score
time frame: 12 months

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
Description Prospective, multicenter, randomized controlled trial comparing balloon dilation of the Eustachian tube to continued medical management for treatment of persistent Eustachian tube dysfunction.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Entellus Medical, Inc..