Trials / Completed
CompletedNCT00939471
Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis
Clinical Evaluation of Confirm the Safety and Efficacy of Balloon Sinuplasty Devices in the Treatment of Pediatric Sinusitis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Integra LifeSciences Corporation · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of balloon sinuplasty devices in pediatric patients with longstanding sinusitis following failed medical management.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Relieva™ Balloon Sinuplasty™ System | Balloon dilation will be performed using endoscopic equipment with video documentation capability. |
Timeline
- Start date
- 2007-04-01
- Primary completion
- 2009-07-01
- Completion
- 2010-05-01
- First posted
- 2009-07-15
- Last updated
- 2024-07-12
- Results posted
- 2012-08-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00939471. Inclusion in this directory is not an endorsement.