Clinical Evaluation of Confirm the Safety and Efficacy of Balloon Sinuplasty Devices in the Treatment of Pediatric Sinusitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Sinusitis
- Sponsor
- Integra LifeSciences Corporation
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \> 2 and \< 18 years
- •Both male and female patients eligible
- •Planned surgical intervention (i.e. endoscopic sinus surgery, adenoidectomy, sinus irrigation for obtaining a culture) recommended by PI, consented to by patient's legal guardian)
- •Longstanding sinusitis: \>3 mo symptoms OR 6 episodes/yr AND failed 2 courses antibiotics followed by positive CT scan
Exclusion Criteria
- •Extensive previous sinonasal surgery in target ostia
- •Cystic fibrosis
- •Extensive sinonasal osteoneogenesis
- •Sinonasal tumors or obstructive lesions
- •History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
- •Ciliary dysfunction
- •For female patients of childbearing age: the patient is either pregnant or lactating
Outcomes
Primary Outcomes
Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months
Time Frame: 12 months
Number of device-related adverse events from time of procedure through 12 months post-procedure.
Effectiveness: Change in Sinus Symptom Scores (SN-5)
Time Frame: 12 months
Change in sinus symptoms (mean reduction) for subjects less than 12 years of age evaluated using the SN-5 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SN-5 is seven and the minimum is one. A reduction in SN-5 score indicates improvement.
Effectiveness: Change in Sinus Symptom Scores (SNOT-20)
Time Frame: 12 months
Change in sinus symptoms (mean reduction) for subjects 12 years of age or greater evaluated using the SNOT-20 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SNOT-20 is five and the minimum is zero. A reduction is SNOT-20 score indicates improvement.
Secondary Outcomes
- Revision Rate(at 1 year)
- Effectiveness: Medication Thru 1 yr(12 months)
- Effectiveness of Dilation/Measured by Post-op Interventions(12 months)
- Days Out of School During the 12 Months of Follow-up(12 months)
- Device Success: Ability to Access/Dilate Sinus Ostia(12 months)