N/A
Completed N=44
Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis
Chronic Sinusitis
Source: ClinicalTrials.gov NCT00939471 ↗
Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcomePrimary: Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months — 0 number of events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months |
— | — |
| PRIMARY Effectiveness: Change in Sinus Symptom Scores (SN-5) |
2.00 | — |
| PRIMARY Effectiveness: Change in Sinus Symptom Scores (SNOT-20) |
0.95 | — |
| SECONDARY Device Success: Ability to Access/Dilate Sinus Ostia |
90.9 | — |
| SECONDARY Effectiveness: Medication Thru 1 yr |
68.3 | — |
| SECONDARY Effectiveness of Dilation/Measured by Post-op Interventions |
— | — |
| SECONDARY Days Out of School During the 12 Months of Follow-up |
5.75 | — |
| SECONDARY Revision Rate |
2 | — |
Eligibility Criteria
Inclusion Criteria
- Age > 2 and 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
Data sourced from ClinicalTrials.gov (NCT00939471). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.