FinESS Registry Study
1 other identifier
observational
500
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2009
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2009
CompletedFirst Posted
Study publicly available on registry
February 24, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedJune 28, 2011
June 1, 2011
2 years
February 20, 2009
June 27, 2011
Conditions
Study Arms (1)
FinESS Treatment
Subjects undergoing treatment with the FinESS Sinus Treatment System
Eligibility Criteria
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.
You may qualify if:
- adults 18 years or older undergoing balloon dilation with FinESS Sinus Treatment and have provided voluntary consent to participate in Registry
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
South Denver ENT and Allergy
Denver, Colorado, United States
Gulf Coast Facial Plastics and ENR
Panama City, Florida, 32405, United States
Gensys Regional Medical Center
Grand Blanc, Michigan, 48439, United States
Paparella Group
Maple Grove, Minnesota, 55311, United States
St. Cloud Ear Nose and Throat
Saint Cloud, Minnesota, 56303, United States
Lee's Summit Ear, Nose and Throat Center
Lee's Summit, Missouri, 64086, United States
Midwest Ear, Nose and Throat
Sioux Falls, South Dakota, 757108, United States
Dickson Ear, Nose and Throat PLC
Dickson, Tennessee, United States
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
Advanced Otolaryngology, PC
Richmond, Virginia, 23235, United States
Advanced Ear, Nose and Throat Specialists
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jeff Grebner
Entellus Medical
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 20, 2009
First Posted
February 24, 2009
Study Start
March 1, 2009
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
June 28, 2011
Record last verified: 2011-06