Sinus Balloon Dilation in Pediatric Patients
XprESS Device and PathAssist Confirmation Tools in Pediatric Patients-Expanded Indication Study
1 other identifier
interventional
50
1 country
4
Brief Summary
Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2014
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 27, 2014
CompletedFirst Posted
Study publicly available on registry
October 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
December 7, 2016
CompletedApril 11, 2017
February 1, 2017
1 year
October 27, 2014
October 13, 2016
March 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Success is defined as the device successfully delivered to the target sinus, inflated, deflated, and withdrawn from the treated sinus.
Index procedure
Complications
Number of subjects who experience complications. Complications are defined as serious device or procedure related adverse events.
Index procedure through 3-month follow-up
Secondary Outcomes (2)
Change in Quality of Life From Baseline Through Completion
Baseline to 6-month follow-up
Number of Subjects Who Undergo a Revision or Additional Surgery During the Study
Procedure-6 month follow up
Study Arms (1)
Balloon Sinus Dilation
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Patients age ≥ 2 to ≤ 21 years old. Diagnosed with Chronic Rhinosinusitis (CRS). Candidate for trans-nasal balloon sinus dilation.
You may not qualify if:
- History of sinus surgery. Recent nasal or head and neck surgery. Fungal sinus disease. Severe asthma. Cystic fibrosis. Immunodeficiency. Craniofacial abnormalities. Pregnancy (current)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
North Valley ENT
Phoenix, Arizona, 85032, United States
Willamette ENT and Facial Plastic Surgery
Salem, Oregon, 97302, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Alamo ENT and Associates
San Antonio, Texas, 78258, United States
Related Publications (1)
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.
PMID: 27888649RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ellen O'Malley
- Organization
- Entellus Medical
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2014
First Posted
October 30, 2014
Study Start
September 1, 2014
Primary Completion
September 1, 2015
Study Completion
January 1, 2016
Last Updated
April 11, 2017
Results First Posted
December 7, 2016
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share