Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis

Not Applicable

Completed

• Conditions: Chronic Sinusitis
• Interventions: Device: Relieva™ Balloon Sinuplasty™ System

• Registration Number: NCT00939471
• Lead Sponsor: Integra LifeSciences Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-01
• Primary Completion: 2009-07-01
• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-14
• Study First Posted: 2009-07-15
• Study Completion: 2010-05-01
• Results First Submitted: 2011-07-20
• Results First Submitted QC: 2012-07-10
• Results First Posted: 2012-08-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. Age > 2 and < 18 years
2. Both male and female patients eligible
3. 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)
4. Longstanding sinusitis: >3 mo symptoms OR 6 episodes/yr AND failed 2 courses antibiotics followed by positive CT scan

Exclusion Criteria

1. Extensive previous sinonasal surgery in target ostia
2. Cystic fibrosis
3. Extensive sinonasal osteoneogenesis
4. Sinonasal tumors or obstructive lesions
5. History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
6. Ciliary dysfunction
7. For female patients of childbearing age: the patient is either pregnant or lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Relieva™ Balloon Sinuplasty™ System	Relieva™ Balloon Sinuplasty™ System	Balloon Dilation of sinus ostium

Primary Outcome Measures

Name	Time	Method
Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months	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)	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)	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 Outcome Measures

Name	Time	Method
Revision Rate	at 1 year	The number of subjects requiring revisions out of 33 subjects treated.
Effectiveness: Medication Thru 1 yr	12 months	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	12 months	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	12 months	Quantitative assessment of days out of school during the 12 months of follow-up.
Device Success: Ability to Access/Dilate Sinus Ostia	12 months	Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted.

Trial Locations

Locations (1)

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States