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Sinus Balloon Dilation in Pediatric Patients

Primary Purpose

Sinusitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
XprESS device and PathAssist confirmation tools
Sponsored by
Entellus Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinusitis focused on measuring sinus infections, sinusitis, chronic sinusitis, rhinosinusitis, allergic sinusitis, allergic rhinitis, chronic rhinosinusitis, sinus disease in children, sinus balloon dilation, balloon dilatation, sinus disease, pediatric

Eligibility Criteria

2 Years - 21 Years (Child, Adult)All SexesDoes not accept 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)

Sites / Locations

  • North Valley ENT
  • Willamette ENT and Facial Plastic Surgery
  • Medical University of South Carolina
  • Alamo ENT and Associates

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Balloon Sinus Dilation

Arm Description

Outcomes

Primary Outcome Measures

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 Success is defined as the device successfully delivered to the target sinus, inflated, deflated, and withdrawn from the treated sinus.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

Secondary Outcome Measures

Change in Quality of Life From Baseline Through Completion
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
Any surgical intervention that is performed in the sinus(es) following the index procedure will be reported

Full Information

First Posted
October 27, 2014
Last Updated
March 13, 2017
Sponsor
Entellus Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02278484
Brief Title
Sinus Balloon Dilation in Pediatric Patients
Official Title
XprESS Device and PathAssist Confirmation Tools in Pediatric Patients-Expanded Indication Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Entellus Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
Keywords
sinus infections, sinusitis, chronic sinusitis, rhinosinusitis, allergic sinusitis, allergic rhinitis, chronic rhinosinusitis, sinus disease in children, sinus balloon dilation, balloon dilatation, sinus disease, pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Balloon Sinus Dilation
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
XprESS device and PathAssist confirmation tools
Primary Outcome Measure Information:
Title
Technical Success: Sinuses Successfully Treated With Balloon Dilation
Description
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.
Time Frame
Index procedure
Title
Complications
Description
Number of subjects who experience complications. Complications are defined as serious device or procedure related adverse events.
Time Frame
Index procedure through 3-month follow-up
Secondary Outcome Measure Information:
Title
Change in Quality of Life From Baseline Through Completion
Description
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.
Time Frame
Baseline to 6-month follow-up
Title
Number of Subjects Who Undergo a Revision or Additional Surgery During the Study
Description
Any surgical intervention that is performed in the sinus(es) following the index procedure will be reported
Time Frame
Procedure-6 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
North Valley ENT
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Willamette ENT and Facial Plastic Surgery
City
Salem
State/Province
Oregon
ZIP/Postal Code
97302
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Alamo ENT and Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27888649
Citation
Soler ZM, Rosenbloom JS, Skarada D, Gutman M, Hoy MJ, Nguyen SA. Prospective, multicenter evaluation of balloon sinus dilation for treatment of pediatric chronic rhinosinusitis. Int Forum Allergy Rhinol. 2017 Mar;7(3):221-229. doi: 10.1002/alr.21889. Epub 2016 Nov 26.
Results Reference
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Sinus Balloon Dilation in Pediatric Patients

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