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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00849953
Other study ID # 1498-001
Secondary ID
Status Completed
Phase N/A
First received February 20, 2009
Last updated June 27, 2011
Start date March 2009
Est. completion date March 2011

Study information

Verified date June 2011
Source Entellus Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
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 South Denver ENT and Allergy Denver Colorado
United States Dickson Ear, Nose and Throat PLC Dickson Tennessee
United States Gensys Regional Medical Center Grand Blanc Michigan
United States Medical Center ENT Associates of Houston Houston Texas
United States Lee's Summit Ear, Nose and Throat Center Lee's Summit Missouri
United States Paparella Group Maple Grove Minnesota
United States Advanced Ear, Nose and Throat Specialists Milwaukee Wisconsin
United States Gulf Coast Facial Plastics and ENR Panama City Florida
United States Advanced Otolaryngology, PC Richmond Virginia
United States Midwest Ear, Nose and Throat Sioux Falls South Dakota
United States St. Cloud Ear Nose and Throat St Cloud Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Entellus Medical, Inc.

Country where clinical trial is conducted

United States, 

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