N/A N=44 Treatment

Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis

Chronic Sinusitis

Bottom Line

View on ClinicalTrials.gov: NCT00939471 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2012

Primary outcome: Primary: Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months — 0 number of events

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Relieva™ Balloon Sinuplasty™ System (Device)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: Integra LifeSciences Corporation
Primary completion: Jul 2009

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	—

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.

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

View full record on ClinicalTrials.gov →

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.