Trials / Completed
CompletedNCT02391584
XprESS Eustachian Tube Dilation Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Entellus Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Study to assess the safety and efficacy of the XprESS device for transnasal Eustachian tube dilation.
Detailed description
Prospective, multicenter, randomized controlled trial comparing balloon dilation of the Eustachian tube to continued medical management for treatment of persistent Eustachian tube dysfunction.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | XprESS | Balloon dilation of the Eustachian tube |
| OTHER | Control | Continued medical management |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2017-03-01
- Completion
- 2017-10-01
- First posted
- 2015-03-18
- Last updated
- 2018-11-01
- Results posted
- 2018-11-01
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02391584. Inclusion in this directory is not an endorsement.