XprESS Eustachian Tube Dilation Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

XprESS ET Registry

NCT04136977

Eustachian Tube Dysfunction

COMPLETED

Novel Imaging of the Eustachian Tube; Patient Study

NCT02282540

Otitis Media With Effusion Eustachian Tube Disorder

COMPLETED NA

Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 3

NCT01925495

Middle-ear Function

TERMINATED EARLY_PHASE1

Hummingbird TTS Ear Tube Delivery Study

NCT02165384

Otitis Media

COMPLETED NA

Pretympanoplasty Assessment of Patency and Mucociliary Function of Eustachian Tube

NCT05229380

Eustachian Tube Dysfunction

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Eustachian Tube Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

XprESS

Balloon dilation of the Eustachian tube

Group Type EXPERIMENTAL

XprESS

Intervention Type DEVICE

Balloon dilation of the Eustachian tube

Control

Continued medical management

Group Type OTHER

Control

Intervention Type OTHER

Continued medical management

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

XprESS

Balloon dilation of the Eustachian tube

Intervention Type DEVICE

Control

Continued medical management

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Continued medical management

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No