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Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis
NA trial testing Relieva™ Balloon Sinuplasty™ System in Chronic Sinusitis in 44 participants. Completed in 1 May 2010.
| Lead sponsor | Integra LifeSciences Corporation |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 44 |
| Start date | 1 April 2007 |
| Primary completion | 1 July 2009 |
| Estimated completion | 1 May 2010 |
| Sites | 1 location across United States |
Integra LifeSciences Corporation — full company profile →
Adults 2 to 17, any sex, with Chronic Sinusitis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of device-related adverse events from time of procedure through 12 months post-procedure.
| Group | Value | 95% CI |
|---|---|---|
| Balloon Sinuplasty Treatment | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Balloon Sinuplasty Treatment | 2.00 | ± 1.40 |
Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted.
| Group | Value | 95% CI |
|---|---|---|
| Balloon Sinuplasty Treatment | 90.9 |
Data was summarized from the Global Patient Assessment Form. Each subject's last observation was used in order to account for any missing data or early termination of subjects. The results indicated represents the proportion of subjects (expressed as a percentage) who reported a decrease in medication usage at the time of their study discontinuation.
| Group | Value | 95% CI |
|---|---|---|
| Balloon Sinuplasty Treatment | 68.3 |
Effectiveness of balloon dilation as measured by the need for post-operative interventions other than revision sinus surgery. This endpoint evaluation includes irrigation and debridement. Number of post-operative interventions reported.
| Group | Value | 95% CI |
|---|---|---|
| Balloon Sinuplasty Treatment | 0 |
Quantitative assessment of days out of school during the 12 months of follow-up.
| Group | Value | 95% CI |
|---|---|---|
| Balloon Sinuplasty Treatment | 5.75 | ± 7.46 |
The number of subjects requiring revisions out of 33 subjects treated.
| Group | Value | 95% CI |
|---|---|---|
| Balloon Sinuplasty Treatment | 2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Balloon Sinuplasty Treatment | 0.95 | ± 0.51 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00939471.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing