FinESS Registry Study
This study has been completed.
Sponsor:
Entellus Medical, Inc.
Information provided by:
Entellus Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00849953
First received: February 20, 2009
Last updated: June 27, 2011
Last verified: June 2011
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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
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 |
Additional relevant MeSH terms:
|
Sinusitis Paranasal Sinus Diseases Nose Diseases |
Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013