Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis (INTACT)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Evaluation of Confirm the Safety and Efficacy of Balloon Sinuplasty Devices in the Treatment of Pediatric Sinusitis|
- Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
- Device Success: Ability to Access/Dilate Sinus Ostia [ Time Frame: 12 months ] [ Designated as safety issue: No ]Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted.
- Effectiveness: Medication Thru 1 yr [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Effectiveness of Dilation/Measured by Post-op Interventions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]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.
- Days Out of School During the 12 Months of Follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]Quantitative assessment of days out of school during the 12 months of follow-up.
- Revision Rate [ Time Frame: at 1 year ] [ Designated as safety issue: No ]The number of subjects requiring revisions out of 33 subjects treated.
|Study Start Date:||April 2007|
|Study Completion Date:||May 2010|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Relieva™ Balloon Sinuplasty™ System
Balloon Dilation of sinus ostium
Device: Relieva™ Balloon Sinuplasty™ System
Balloon dilation will be performed using endoscopic equipment with video documentation capability.
Other Name: Relieva
|United States, West Virginia|
|West Virginia University|
|Morgantown, West Virginia, United States, 26506|
|Principal Investigator:||Hassan Ramadan, MD||West Virginia University|