RELIEF: Healthcase Utilization and Outcomes of FinESS Treatment in the Office

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Entellus Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00986830
First received: September 29, 2009
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

A prospective, non-randomized trial to evaluate post-operative health care resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office.


Condition Intervention
Rhinosinusitis
Device: FinESS Sinus Treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Healthcare Utilization and Outcomes of FinESS Treatment in the Office

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

Primary Outcome Measures:
  • Health Care Utilization [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in quality of life questionnaires [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: September 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Detailed Description:

A prospective, non-randomized trial to evaluate post-operative health care resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office. Also to demonstrate the long term durability of FinESS Sinus Treatment performed in an office setting.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Male or Female subjects
  • Diagnosis of rhinosinusitis (CT radiographic evidence and Medical Evaluation)
  • Willing to comply ith protocol requirements
  • Able to provide consent

Exclusion Criteria:

  • Hemophilia
  • Cystic Fibrosis
  • Ciliary Dysfunction
  • Severe septal deviation causing obstruction of the ostiomeatal unit
  • Pregnant females
  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: NCT00986830

Locations
United States, California
Central California ENT
Fresno, California, United States, 93720
United States, Colorado
South Denver ENT and Allergy
Denver, Colorado, United States
United States, Connecticut
ENT and Allergy Associates
Trumbull, Connecticut, United States, 06611
United States, Illinois
NorthShore University
Evanston, Illinois, United States
United States, Kentucky
Advanced ENT and Allergy
Louisville, Kentucky, United States, 40207
United States, Minnesota
St. Cloud Ear, Nose and Throat
St. Cloud, Minnesota, United States
United States, North Carolina
Coastal Ear, Nose and Throat Associates
New Bern, North Carolina, United States, 28562
United States, South Dakota
Midwest Ear, Nose and Throat
Sioux Falls, South Dakota, United States, 57108
United States, Tennessee
Holston Medical Center
Kingsport, Tennessee, United States, 37660
United States, Texas
Austin Ear, Nose and Throat
Austin, Texas, United States
Texas Sinus Center
Boerne, Texas, United States, 78006
The Snoring Center
Dallas, Texas, United States
United States, Virginia
Advanced Otolaryngology PC
Richmond, Virginia, United States, 23235
Sponsors and Collaborators
Entellus Medical, Inc.
  More Information

Publications:
Responsible Party: Entellus Medical, Inc.
ClinicalTrials.gov Identifier: NCT00986830     History of Changes
Other Study ID Numbers: 1630-001
Study First Received: September 29, 2009
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Entellus Medical, Inc.:
Rhinosinusitis
Balloon catheters
Office treatment
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
FinESS Sinus Treatment
endoscopic sinus surgery

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 21, 2014