Trials / Completed
CompletedNCT00645762
Balloon REmodeling Antrostomy THErapy Study
Balloon REmodeling Antrostomy THErapy Study (BREATHE I)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 71 (actual)
- Sponsor
- Entellus Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to evaluate safety and effectiveness of a less invasive procedure to treat maxillary only, or maxillary and anterior ethmoid, chronic sinusitis. Additionally, this study will assess the feasibility of performing the procedure under local anesthesia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RS-Series Rhinosinusitis Treatment System | Single arm |
| DEVICE | FinESS Balloon |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2010-06-01
- Completion
- 2010-06-01
- First posted
- 2008-03-28
- Last updated
- 2013-07-29
- Results posted
- 2013-07-29
Locations
13 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00645762. Inclusion in this directory is not an endorsement.