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FinESS Registry Study

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ClinicalTrials.gov Identifier: NCT00849953
Recruitment Status : Completed
First Posted : February 24, 2009
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:
Entellus Medical, Inc.

Brief Summary:
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.

Condition or disease
Rhinosinusitis

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: FinESS Registry Study
Study Start Date : March 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

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




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00849953


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

Responsible Party: Entellus Medical
ClinicalTrials.gov Identifier: NCT00849953     History of Changes
Other Study ID Numbers: 1498-001
First Posted: February 24, 2009    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: June 2011