N/A N=50 Treatment

Sinus Balloon Dilation in Pediatric Patients

Sinusitis

Bottom Line

View on ClinicalTrials.gov: NCT02278484 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2016

Primary outcome: Primary: Technical Success: Sinuses Successfully Treated With Balloon Dilation — 157 sinus dilation attempts

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: XprESS device and PathAssist confirmation tools (Device)
Age: Pediatric, Adult · 2+ yrs
Sex: All
Sponsor: Entellus Medical, Inc.
Primary completion: Sep 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Technical Success: Sinuses Successfully Treated With Balloon Dilation	157	—
PRIMARY Complications	—	—
SECONDARY Change in Quality of Life From Baseline Through Completion	-2.9	<0.0001 sig
SECONDARY Number of Subjects Who Undergo a Revision or Additional Surgery During the Study	—	—

Summary

Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.

Eligibility Criteria

Inclusion Criteria

Patients age ≥ 2 to ≤ 21 years old. Diagnosed with Chronic Rhinosinusitis (CRS). Candidate for trans-nasal balloon sinus dilation.

Exclusion Criteria

History of sinus surgery. Recent nasal or head and neck surgery. Fungal sinus disease. Severe asthma. Cystic fibrosis. Immunodeficiency. Craniofacial abnormalities. Pregnancy (current)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02278484). 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.