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Completed

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.

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Key information

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

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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

FinESS Sinus Treatment

Device

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

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