Trials / Completed
CompletedNCT01107379
Optimization and Refinement of Technique in In-Office Sinus Dilation 2
Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS 2)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 203 (actual)
- Sponsor
- Integra LifeSciences Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA cleared for sale in the U.S.A.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Relieva Balloon Sinuplasty System | Sinuplasty balloon tools for dilation of sinuses in patients with chronic rhinosinusitis |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2012-01-01
- Completion
- 2012-07-01
- First posted
- 2010-04-21
- Last updated
- 2024-08-06
- Results posted
- 2014-09-18
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01107379. Inclusion in this directory is not an endorsement.