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FinESS Registry Study

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


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)
FinESS Treatment
Subjects undergoing treatment with the FinESS Sinus Treatment System


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.

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:

  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 identifier: NCT00849953

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Capital Otolaryngology
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Advanced Otolaryngology, PC
Richmond, Virginia, United States, 23235
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Advanced Ear, Nose and Throat Specialists
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Entellus Medical, Inc.
Study Director: Jeff Grebner Entellus Medical
  More Information

Responsible Party: Entellus Medical Identifier: NCT00849953     History of Changes
Other Study ID Numbers: 1498-001
Study First Received: February 20, 2009
Last Updated: June 27, 2011 processed this record on September 19, 2017