Sinus Balloon Dilation in Pediatric Patients

Entellus Medical

Status: Completed

Conditions: Sinusitis

Treatments: Device: XprESS device and PathAssist confirmation tools

Study type: Interventional

Funder types: Industry

Identifiers

NCT02278484

2827-001

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 2 to 21 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Balloon Sinus Dilation

Other group

Treatment:

Device: XprESS device and PathAssist confirmation tools