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XprESS Eustachian Tube Dilation Study

NCT02391584 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-11-01

Study results available
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Summary

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

Conditions

  • Eustachian Tube Dysfunction

Interventions

DEVICE

XprESS

Balloon dilation of the Eustachian tube

OTHER

Control

Continued medical management

Sponsors & Collaborators

  • Entellus Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-03-31
Completion
2017-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02391584 on ClinicalTrials.gov