Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis

Integra LifeSciences Corporation44 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Sinusitis

Interventions

Relieva™ Balloon Sinuplasty™ SystemDEVICE

Balloon dilation will be performed using endoscopic equipment with video documentation capability.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

West Virginia University

Morgantown, West Virginia, United States

Outcomes

Primary Outcomes

Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months

Number of device-related adverse events from time of procedure through 12 months post-procedure.

Time frame: 12 months

Effectiveness: Change in Sinus Symptom Scores (SN-5)

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.

Time frame: 12 months

Effectiveness: Change in Sinus Symptom Scores (SNOT-20)

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.

Time frame: 12 months

Secondary Outcomes

Device Success: Ability to Access/Dilate Sinus Ostia

Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted.

Time frame: 12 months

Effectiveness: Medication Thru 1 yr

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.

Time frame: 12 months

Effectiveness of Dilation/Measured by Post-op Interventions

Data from ClinicalTrials.gov

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