Trials / Completed
CompletedNCT00231062
Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 115 (actual)
- Sponsor
- Integra LifeSciences Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal sinuses.
Detailed description
Sinusitis is a common healthcare problem that significantly reduces quality of life for people around the world. Patients suffer from headache, facial discomfort, nasal congestion, nasal drainage, loss of the sense of smell and malaise. Sinusitis is responsible for major healthcare expenditure and loss of workplace productivity. The rationale of this study is to collect data on the effectiveness and safety of balloon dilation of the Frontal, Maxillary and Sphenoid sinuses by treating patients and observing them for a six month period of time following the procedure. Six month follow-up data is important to demonstrate the effectiveness of balloon catheter dilation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sinuplasty |
Timeline
- Start date
- 2005-04-01
- Primary completion
- 2006-06-01
- Completion
- 2006-06-01
- First posted
- 2005-10-04
- Last updated
- 2024-08-06
- Results posted
- 2011-07-08
Source: ClinicalTrials.gov record NCT00231062. Inclusion in this directory is not an endorsement.