Sinus Balloon Dilation in Pediatric Patients

Sinusitis Clinical Trial

Official title:

XprESS Device and PathAssist Confirmation Tools in Pediatric Patients-Expanded Indication Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02278484
• Other study ID #: 2827-001
• 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

• Sinusitis

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