FinESS Registry Study

This study has been completed.
Sponsor:
Information provided by:
Entellus Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00849953
First received: February 20, 2009
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

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
Rhinosinusitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: FinESS Registry Study

Further study details as provided by Entellus Medical, Inc.:

Estimated Enrollment: 500
Study Start Date: March 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
FinESS Treatment
Subjects undergoing treatment with the FinESS Sinus Treatment System

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Entellus Medical
ClinicalTrials.gov Identifier: NCT00849953     History of Changes
Other Study ID Numbers: 1498-001
Study First Received: February 20, 2009
Last Updated: June 27, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 19, 2014