This trial is active, not recruiting.

Condition sinusitis
Treatment xpress device and pathassist confirmation tools
Sponsor Entellus Medical, Inc.
Start date September 2014
End date September 2015
Trial size 50 participants
Trial identifier NCT02278484, 2827-001


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Single Arm Study of XprESS and PathAssist Devices.
xpress device and pathassist confirmation tools
XprESS Multi-Sinus Dilation Tool intended to remodel sinus outflow tracts. PathAssist confirmation tools intended to access, locate and illuminate sinus spaces.

Primary Outcomes

Number of subjects who successfully undergo sinus balloon dilation procedure
time frame: Index procedure

Secondary Outcomes

Number of subjects who experience complications
time frame: Index procedure through 3 month follow up

Eligibility Criteria

Male or female participants from 2 years up to 21 years old.

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. Allergic to nickel or barium sulfate. Severe asthma. Cystic fibrosis. Immunodeficiency. Craniofacial abnormalities. Pregnancy (current)

Additional Information

Official title XprESS Device and PathAssist Confirmation Tools in Pediatric Patients-Expanded Indication Study
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Entellus Medical, Inc..