Sinus Balloon Dilation in Pediatric Patients

NCT ID: NCT02278484

Last Updated: 2017-04-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-01-31

Brief Summary

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

Detailed Description

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Conditions

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Sinusitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Balloon Sinus Dilation

Group Type OTHER

XprESS device and PathAssist confirmation tools

Intervention Type DEVICE

Interventions

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XprESS device and PathAssist confirmation tools

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

2 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Entellus Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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North Valley ENT

Phoenix, Arizona, United States

Site Status

Willamette ENT and Facial Plastic Surgery

Salem, Oregon, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Alamo ENT and Associates

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 27888649 (View on PubMed)

Other Identifiers

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2827-001

Identifier Type: -

Identifier Source: org_study_id

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