RELIEF: Healthcase Utilization and Outcomes of FinESS Treatment in the Office
This study has been completed.
Sponsor:
Entellus Medical, Inc.
Information provided by (Responsible Party):
Entellus Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00986830
First received: September 29, 2009
Last updated: February 12, 2013
Last verified: February 2013
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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) |
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
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
No publications provided
| 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: | February 12, 2013 |
| 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 May 22, 2013