FinESS Registry Study

NCT ID: NCT00849953

Last Updated: 2011-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-03-31

Brief Summary

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A prospective, post-approval registry study assessing subject rhinosinusitis symptomatic status over time following treatment with FinESS Sinus Treatment using self-administered quality of life survey data.

Detailed Description

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Conditions

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Rhinosinusitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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FinESS Treatment

Subjects undergoing treatment with the FinESS Sinus Treatment System

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* adults 18 years or older undergoing balloon dilation with FinESS Sinus Treatment and have provided voluntary consent to participate in Registry

Exclusion Criteria

* none
Minimum Eligible Age

18 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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Entellus Medical

Principal Investigators

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Jeff Grebner

Role: STUDY_DIRECTOR

Entellus Medical

Locations

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South Denver ENT and Allergy

Denver, Colorado, United States

Site Status

Gulf Coast Facial Plastics and ENR

Panama City, Florida, United States

Site Status

Gensys Regional Medical Center

Grand Blanc, Michigan, United States

Site Status

Paparella Group

Maple Grove, Minnesota, United States

Site Status

St. Cloud Ear Nose and Throat

Saint Cloud, Minnesota, United States

Site Status

Lee's Summit Ear, Nose and Throat Center

Lee's Summit, Missouri, United States

Site Status

Midwest Ear, Nose and Throat

Sioux Falls, South Dakota, United States

Site Status

Dickson Ear, Nose and Throat PLC

Dickson, Tennessee, United States

Site Status

Austin Ear, Nose and Throat Clinic

Austin, Texas, United States

Site Status

Capital Otolaryngology

Austin, Texas, United States

Site Status

Texas Sinus Center

Boerne, Texas, United States

Site Status

Medical Center ENT Associates of Houston

Houston, Texas, United States

Site Status

Advanced Otolaryngology, PC

Richmond, Virginia, United States

Site Status

Advanced Ear, Nose and Throat Specialists

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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1498-001

Identifier Type: -

Identifier Source: org_study_id

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