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OpenTrials
Completed

NCT Number: NCT02278484

Sinus Balloon Dilation in Pediatric Patients

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

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Key information

Conditions

Sinusitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinitis, Allergic Rhinosinusitis

Age range

2 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Valley ENT, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

XprESS device and PathAssist confirmation tools

Device

Primary outcomes

  1. 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 Success is defined as the device successfully delivered to the target sinus, inflated, deflated, and withdrawn from the treated sinus.

  2. 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 outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Entellus Medical, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 30, 2014
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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