Sinus Balloon Dilation in Pediatric Patients

Not Applicable

Completed

• Conditions: Sinusitis
• Interventions: Device: XprESS device and PathAssist confirmation tools

• Registration Number: NCT02278484
• Lead Sponsor: Entellus Medical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-27
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-30
• Primary Completion: 2015-09
• Study Completion: 2016-01
• Results First Submitted: 2016-10-13
• Results First Submitted QC: 2016-10-13
• Results First Posted: 2016-12-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Balloon Sinus Dilation	XprESS device and PathAssist confirmation tools	-

Primary Outcome Measures

Name	Time	Method
Technical Success: Sinuses Successfully Treated With Balloon Dilation	Index procedure	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 Success is defined as the device successfully delivered to the target sinus, inflated, deflated, and withdrawn from the treated sinus.
Complications	Index procedure through 3-month follow-up	Number of subjects who experience complications. Complications are defined as serious device or procedure related adverse events.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life From Baseline Through Completion	Baseline to 6-month follow-up	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.
Number of Subjects Who Undergo a Revision or Additional Surgery During the Study	Procedure-6 month follow up	Any surgical intervention that is performed in the sinus(es) following the index procedure will be reported

Trial Locations

Locations (4)

North Valley ENT; 🇺🇸 Phoenix, Arizona, United States

Alamo ENT and Associates; 🇺🇸 San Antonio, Texas, United States

Willamette ENT and Facial Plastic Surgery; 🇺🇸 Salem, Oregon, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States