Sinus Balloon Dilation in Pediatric Patients

N/ACompletedNCT02278484

Entellus Medical, Inc.50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sinusitis

Interventions

XprESS device and PathAssist confirmation toolsDEVICE

Eligibility

Sex: ALLMin age: 2 YearsMax age: 21 Years

Medical Language ↔ Plain English

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)

Locations (4)

North Valley ENT

Phoenix, Arizona, United States

Willamette ENT and Facial Plastic Surgery

Salem, Oregon, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Alamo ENT and Associates

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Technical Success: Sinuses Successfully Treated With Balloon Dilation

Number of successful dilations out of all attempted dilations. Success is defined as the device successfully delivered to the target sinus, inflated, deflated, and withdrawn from the treated sinus.

Time frame: Index procedure

Complications

Number of subjects who experience complications. Complications are defined as serious device or procedure related adverse events.

Time frame: Index procedure through 3-month follow-up

Secondary Outcomes

Change in Quality of Life From Baseline Through Completion

Change in sinonasal symptom severity between the baseline preprocedure assessment and follow-up assessment. Sinus symptom severity is measured using the Sinus and Nasal Quality of Life Survey (SN-5) that is a validated tool for use in pediatric patients (completed by caregivers). The 5 survey items are scored from 1 (best) to 7 (worst) and averaged to provide an overall score.

Time frame: Baseline to 6-month follow-up

Number of Subjects Who Undergo a Revision or Additional Surgery During the Study

Any surgical intervention that is performed in the sinus(es) following the index procedure will be reported

Time frame: Procedure-6 month follow up

Data from ClinicalTrials.gov

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