Sinus Balloon Dilation in Pediatric Patients

March 13, 2017 updated by: Entellus Medical, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • North Valley ENT
    • Oregon
      • Salem, Oregon, United States, 97302
        • Willamette ENT and Facial Plastic Surgery
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • San Antonio, Texas, United States, 78258
        • Alamo ENT and Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Balloon Sinus Dilation
Device: XprESS device and PathAssist confirmation tools

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success: Sinuses Successfully Treated With Balloon Dilation
Time Frame: 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.
Index procedure
Complications
Time Frame: Index procedure through 3-month follow-up
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Entellus Medical, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

October 27, 2014

First Submitted That Met QC Criteria

October 27, 2014

First Posted (Estimate)

October 30, 2014

Study Record Updates

Last Update Posted (Actual)

April 11, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2827-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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