RhinosinusitisRELIEFNCT00986830
Healthcare Utilization and Outcomes of FinESS Treatment in the Office
A study testing FinESS Sinus Treatment in people with Rhinosinusitis, run by Entellus Medical, Inc. at 13 sites in United States.
Trial summary
A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinosinusitis
- What is being tested?
- FinESS Sinus Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 13 sitesUnited States
- Study dates
- Sep 2009to Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hemophilia
- Cystic fibrosis
- Ciliary dysfunction
- Severe septal deviation causing obstruction of the ostiomeatal unit
- Pregnant females
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Austin Ear, Nose and Throat
Austin, Texas, 78705
Texas Sinus Center
Boerne, Texas, 78006
The Snoring Center
Dallas, Texas, 75205
South Denver ENT and Allergy
Denver, Colorado, 80120
NorthShore University
Evanston, Illinois, 60201
Central California ENT
Fresno, California, 93720
Holston Medical Center
Kingsport, Tennessee, 37660
Advanced ENT and Allergy
Louisville, Kentucky, 40207
Coastal Ear, Nose and Throat Associates
New Bern, North Carolina, 28562
Advanced Otolaryngology PC
Richmond, Virginia, 23235
St. Cloud Ear, Nose and Throat
Saint Cloud, Minnesota, 56303
Midwest Ear, Nose and Throat
Sioux Falls, South Dakota, 57108
ENT and Allergy Associates
Trumbull, Connecticut, 06611
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.
Read the detailed description
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.
- Conditions
- Rhinosinusitis
- Being tested
- FinESS Sinus Treatment
- Keywords
- Rhinosinusitis, Balloon catheters, Office treatment, Otorhinolaryngologic diseases, Respiratory tract infections, Respiratory tract diseases, FinESS Sinus Treatment, Endoscopic sinus surgery
- Medical subject headings
- Rhinosinusitis, Otorhinolaryngologic Diseases, Respiratory Tract Infections, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinESS Sinus TreatmentDevice
| Study group | Role | What they receive |
|---|---|---|
| Balloon Dilation | Experimental | Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device. Receives: Device: FinESS Sinus Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sino-Nasal Outcomes Test
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.
Measured: Baseline and 12 months post procedure
Secondary outcomes (8)
Rhinosinusitis Symptom Inventory (RSI) Nasal Symptoms Domain
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.
Measured: Baseline and 12 months post procedure
Rhinosinusitis Symptom Inventory (RSI) Facial Symptoms Domain
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.
Measured: Baseline and 12 months post procedure
Rhinosinusitis Symptom Inventory (RSI) Oropharyngeal Symptoms Domain
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.
Measured: Baseline and 12 months post procedure
Rhinosinusitis Symptom Inventory (RSI) Systemic Symptoms Domain
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.
Measured: Baseline and 12 months post procedure
Number of Participants Using Nasal Steroids
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.
Measured: Baseline and 12 months post procedure
Number of Participants Using Antihistamines
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.
Measured: Baseline and 12 months post procedure
Number of Participants Using Antibiotics
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.
Measured: Baseline and 12 months post procedure
Number of Participants With Device and/or Procedure-related Adverse Events
Number of participants with 1 or more adverse events considered possibly or definitely related to the FinESS device and/or balloon dilation procedure.
Measured: Baseline through 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RhinosinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entellus Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986830
- Sponsor's protocol ID
- 1630-001
- Acronym
- RELIEF
- Status last verified
- Oct 2020
- First submitted
- 29 Sep 2009
- Last updated
- 27 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Levine SB, Truitt T, Schwartz M, Atkins J. In-office stand-alone balloon dilation of maxillary sinus ostia and ethmoid infundibula in adults with chronic or recurrent acute rhinosinusitis: a prospective, multi-institutional study with-1-year follow-up. Ann Otol Rhinol Laryngol. 2013 Nov;122(11):665-71. doi: 10.1177/000348941312201101.
PubMed 24358625
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthcare Utilization and Outcomes of FinESS Treatment in the Office
- ClinicalTrials.gov ID
- NCT00986830
- Acronym / sponsor ID
- RELIEF / 1630-001
- Conditions
- Rhinosinusitis
- Keywords
- Rhinosinusitis, Balloon catheters, Office treatment, Otorhinolaryngologic diseases, Respiratory tract infections, Respiratory tract diseases, FinESS Sinus Treatment, Endoscopic sinus surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Entellus Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 Sep 2009 (estimated)
- Results
- Posted 27 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Balloon Dilation | Experimental | Device: FinESS Sinus TreatmentBalloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Hemophilia
- Cystic fibrosis
- Ciliary dysfunction
- Severe septal deviation causing obstruction of the ostiomeatal unit
- Pregnant females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FinESS Sinus Treatment | Device | Balloon Dilation |
Primary outcome
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.
8 secondary outcomes
Rhinosinusitis Symptom Inventory (RSI) Nasal Symptoms Domain
Time frame: Baseline and 12 months post procedure
Rhinosinusitis Symptom Inventory (RSI) Facial Symptoms Domain
Time frame: Baseline and 12 months post procedure
Rhinosinusitis Symptom Inventory (RSI) Oropharyngeal Symptoms Domain
Time frame: Baseline and 12 months post procedure
Rhinosinusitis Symptom Inventory (RSI) Systemic Symptoms Domain
Time frame: Baseline and 12 months post procedure
Number of Participants Using Nasal Steroids
Time frame: Baseline and 12 months post procedure
Number of Participants Using Antihistamines
Time frame: Baseline and 12 months post procedure
Number of Participants Using Antibiotics
Time frame: Baseline and 12 months post procedure
Number of Participants With Device and/or Procedure-related Adverse Events
Time frame: Baseline through 12 months post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24358625Levine SB, Truitt T, Schwartz M, Atkins J. In-office stand-alone balloon dilation of maxillary sinus ostia and ethmoid infundibula in adults with chronic or recurrent acute rhinosinusitis: a prospective, multi-institutional study with-1-year follow-up. Ann Otol Rhinol Laryngol. 2013 Nov;122(11):665-71. doi: 10.1177/000348941312201101.
- Individual participant dataSharing planned: No
Related trials for Rhinosinusitis
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Nasal Polyps
RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FinESS Sinus Treatment in people with Rhinosinusitis, run by Entellus Medical, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sino-Nasal Outcomes Test (time frame: Baseline and 12 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00986830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.