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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02278484
Other study ID # 2827-001
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 27, 2014
Last updated July 28, 2015
Start date September 2014
Est. completion date January 2016

Study information

Verified date July 2015
Source Entellus Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date January 2016
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 21 Years
Eligibility 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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
United States Advanced Otolaryngology Associates Reno Nevada

Sponsors (1)

Lead Sponsor Collaborator
Entellus Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in quality of life from baseline through completion change in sinonasal symptom severity between the baseline pre-procedure assessment and follow-up assessment. Baseline- 6 month follow up No
Other 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 Procedure-6 month follow up No
Primary Number of subjects who successfully undergo sinus balloon dilation procedure Is the device successfully delivered to the target location, inflated, deflated and withdrawn from the treated sinus. Index procedure Yes
Secondary Number of subjects who experience complications Device or procedure related adverse events Index procedure through 3 month follow up Yes
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