Trials / Completed
CompletedNCT04136977
XprESS ET Registry
XprESS Eustachian Tube Balloon Dilation Registry
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 169 (actual)
- Sponsor
- Entellus Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, multicenter, registry of patients undergoing balloon dilation of the Eustachian tubes (ET).
Detailed description
This is a prospective, multicenter, single-arm, postmarket registry enrolling up to 300 participants who are planning to undergo balloon dilation of the Eustachian tubes for treatment of chronic/persistent Eustachian tube dysfunction (ETD). Procedural information will be collect as well as efficacy and safety data through 6 months post procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Eustachian tube dilation | Unilateral or bilateral balloon dilation of the Eustachian tube using the FDA-cleared XprESS ENT Dilation System |
Timeline
- Start date
- 2018-06-05
- Primary completion
- 2020-08-28
- Completion
- 2020-08-28
- First posted
- 2019-10-23
- Last updated
- 2020-09-30
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04136977. Inclusion in this directory is not an endorsement.