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Sinus Balloon Dilation in Pediatric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Entellus Medical, Inc.
ClinicalTrials.gov Identifier:
NCT02278484
First received: October 27, 2014
Last updated: March 13, 2017
Last verified: February 2017
  Purpose
Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.

Condition Intervention
Sinusitis Device: XprESS device and PathAssist confirmation tools

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: XprESS Device and PathAssist Confirmation Tools in Pediatric Patients-Expanded Indication Study

Resource links provided by NLM:


Further study details as provided by Entellus Medical, Inc.:

Primary Outcome Measures:
  • 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 Success is defined as the device successfully delivered to the target sinus, inflated, deflated, and withdrawn from the treated sinus.

  • 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.


Secondary Outcome Measures:
  • 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.

  • 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


Enrollment: 50
Study Start Date: September 2014
Study Completion Date: January 2016
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Balloon Sinus Dilation Device: XprESS device and PathAssist confirmation tools

  Eligibility

Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02278484

Locations
United States, Arizona
North Valley ENT
Phoenix, Arizona, United States, 85032
United States, Oregon
Willamette ENT and Facial Plastic Surgery
Salem, Oregon, United States, 97302
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Alamo ENT and Associates
San Antonio, Texas, United States, 78258
Sponsors and Collaborators
Entellus Medical, Inc.
  More Information

Publications:
Responsible Party: Entellus Medical, Inc.
ClinicalTrials.gov Identifier: NCT02278484     History of Changes
Other Study ID Numbers: 2827-001
Study First Received: October 27, 2014
Results First Received: October 13, 2016
Last Updated: March 13, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Entellus Medical, Inc.:
sinus infections
sinusitis
chronic sinusitis
rhinosinusitis
allergic sinusitis
allergic rhinitis
chronic rhinosinusitis
sinus disease in children
sinus balloon dilation
balloon dilatation
sinus disease
pediatric

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 18, 2017