NCT Number: NCT00986830
Healthcare Utilization and Outcomes of FinESS Treatment in the Office
A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Central California ENT, Fresno, California, United States
About this study
A prospective, nonrandomized trial to evaluate postoperative healthcare 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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 18 years or older
- Male or female subjects
- Diagnosis of rhinosinusitis (CT radiographic evidence and medical evaluation)
- Willing to comply with protocol requirements
- Able to provide consent
Exclusion criteria
- Hemophilia
- Cystic fibrosis
- Ciliary dysfunction
- Severe septal deviation causing obstruction of the ostiomeatal unit
- Pregnant females
Treatment and study plan
Primary outcomes
-
Sino-Nasal Outcomes Test
Time frame: Baseline and 12 months post procedure
The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated, disease-specific patient-reported instrument designed to indicate the severity of rhinosinusitis symptoms. The SNOT-20 evaluates 20 symptoms on a scale from 0 ("no problem") to 5 ("problem as bad as it can be"). The overall SNOT-20 score is the average of the 20 symptoms scores providing a range from 0 to 5 with higher scores indicating worse symptoms. The minimal clinically important difference (MCID) has been determined to be a reduction of 0.8 or more in the overall SNOT-20 score.
Secondary outcomes
-
Rhinosinusitis Symptom Inventory (RSI) Nasal Symptoms Domain
Time frame: Baseline and 12 months post procedure
The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with "0" indicating no symptoms and "5" indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms.
-
Rhinosinusitis Symptom Inventory (RSI) Facial Symptoms Domain
Time frame: Baseline and 12 months post procedure
The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with "0" indicating no symptoms and "5" indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms.
-
Rhinosinusitis Symptom Inventory (RSI) Oropharyngeal Symptoms Domain
Time frame: Baseline and 12 months post procedure
The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with "0" indicating no symptoms and "5" indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms.
-
Rhinosinusitis Symptom Inventory (RSI) Systemic Symptoms Domain
Time frame: Baseline and 12 months post procedure
The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with "0" indicating no symptoms and "5" indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms.
-
Number of Participants Using Nasal Steroids
Time frame: Baseline and 12 months post procedure
The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 2 of the questionnaire records medication usage (nasal steroid sprays, anti-histamines, and antibiotics) over the past 12 months.
-
Number of Participants Using Antihistamines
Time frame: Baseline and 12 months post procedure
The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 2 of the questionnaire records medication usage (nasal steroid sprays, anti-histamines, and antibiotics) over the past 12 months.
-
Number of Participants Using Antibiotics
Time frame: Baseline and 12 months post procedure
The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 2 of the questionnaire records medication usage (nasal steroid sprays, anti-histamines, and antibiotics) over the past 12 months.
-
Number of Participants With Device and/or Procedure-related Adverse Events
Time frame: Baseline through 12 months post procedure
Number of participants with 1 or more adverse events considered possibly or definitely related to the FinESS device and/or balloon dilation procedure.
Sponsors and collaborators
Lead sponsor
Entellus Medical, Inc.
Industry
Registry information
Acronym: RELIEF
Important dates
- Study start
- 2009
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Sep 30, 2009
- Registry last updated
- Oct 27, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Longitudinal Deep Phenotyping of Central Mechanisms in Dysosmia: A Pilot Study Using Electrobulbogram (EBG), Functional MRI (fMRI), and Diffusion-Weighted Imaging (DWI)
NCT07149428
Anosmia, Behavior
Bethesda, Maryland, United States
View Trial DetailsPost-market Clinical Follow-up Study of an Isotonic Saline Solution to Manage Nasal Congestion in Case of Flu Symptoms, Colds, Allergic Rhinitis and Rhinosinusitis in Infants and Toddlers
NCT07257224
Airway Obstruction, Allergic Rhinitis
Alicante, Spain
View Trial DetailsClinical Outcomes and Patient Satisfaction With Velnez Versus Nasopore in Nasal Surgery
NCT07560254
Chronic Rhino-sinusitis, Infections
Sungai Buloh, Selangor, Malaysia
View Trial DetailsDexmedetomidine Infusion in Either Total Intravenous Anesthesia or Inhalational Anesthesia to Improve Surgical Field Visibility in Endoscopic Sinus Surgery
NCT06866145
Infections, Nose Diseases
Menoufia, Shibin Elkom, Egypt
View Trial Details