FinESS Registry Study

June 27, 2011 updated by: Entellus Medical, Inc.
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

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
    • Colorado
      • Denver, Colorado, United States
        • South Denver ENT and Allergy
    • Florida
      • Panama City, Florida, United States, 32405
        • Gulf Coast Facial Plastics and ENR
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Gensys Regional Medical Center
    • Minnesota
      • Maple Grove, Minnesota, United States, 55311
        • Paparella Group
      • St Cloud, Minnesota, United States, 56303
        • St. Cloud Ear Nose and Throat
    • Missouri
      • Lee's Summit, Missouri, United States, 64086
        • Lee's Summit Ear, Nose and Throat Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 757108
        • Midwest Ear, Nose and Throat
    • Tennessee
      • Dickson, Tennessee, United States
        • Dickson Ear, Nose and Throat PLC
    • Texas
      • Austin, Texas, United States
        • Austin Ear, Nose and Throat Clinic
      • Austin, Texas, United States
        • Capital Otolaryngology
      • Boerne, Texas, United States
        • Texas Sinus Center
      • Houston, Texas, United States
        • Medical Center ENT Associates of Houston
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Advanced Otolaryngology, PC
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Advanced Ear, Nose and Throat Specialists

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who in the investigator's opinion, require trans-antral treatment of the maxillary sinus ostium and ethmoid infundibulum to remodel the bony sinus outflow tract using balloon displacement of adjacent bone and paranasal sinus structures using FinESS Sinus Treatment.

Description

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

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

Cohorts and Interventions

Group / Cohort
FinESS Treatment
Subjects undergoing treatment with the FinESS Sinus Treatment System

Collaborators and Investigators

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

Sponsor

Entellus Medical, Inc.

Investigators

  • Study Director: Jeff Grebner, Entellus Medical

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

March 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

February 20, 2009

First Submitted That Met QC Criteria

February 20, 2009

First Posted (Estimate)

February 24, 2009

Study Record Updates

Last Update Posted (Estimate)

June 28, 2011

Last Update Submitted That Met QC Criteria

June 27, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 1498-001

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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