Back to resultsA Study of RhinAer ARC Stylus for Treating Chronic Rhinitis (RELIEF) (RELIEF)
Primary Purpose
Chronic Rhinitis
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
RhinAer ARC Stylus
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinitis
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 85 years (inclusively).
- Willing and able to provide informed consent.
- Willing and able to comply with the subject-specific requirements outlined in the Study Protocol.
- Seeking treatment for chronic rhinitis symptoms of at least 6 months duration and willing to undergo an office-based procedure.
- Moderate to severe symptoms of rhinorrhea (rTNSS rating of 2 or 3 for rhinorrhea).
- Mild to severe symptoms of nasal congestion (rTNSS rating of 1, 2 or 3 for congestion).
- rTNSS ≥ 6.
Exclusion Criteria:
- Anatomic obstructions that in the investigator's opinion limit access to the posterior nasal passage.
- Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery or injury.
- Active nasal or sinus infection.
- History of significant dry eye.
- History of any of the following: chronic epistaxis, documented episodes of significant nose bleeds in the past 3 months, rhinitis medicamentosa, head or neck irradiation.
- Have rhinitis symptoms only on a seasonal basis due to allergies.
- Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session.
- Known or suspected to be pregnant or is lactating.
- Participating in another clinical research study.
- Has any condition that predisposes to excessive bleeding.
- Is taking anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be discontinued before the procedure.
- Has previous procedure or surgery for chronic rhinitis.
- Other medical conditions which in the opinion of the investigator would predispose the subject to poor wound healing, increased surgical risk, or poor compliance with the requirements of the study.
Sites / Locations
- Arizona Desert ENT Specialists
- Sacramento ENT
- University of California, San Francisco
- ENT Associates of South Florida
- ENT and Allergy Associates of Florida
- Florida ENT and Allergy
- Chicago Nasal and Sinus Center
- Advanced ENT and Allergy
- Baton Rouge General / Sinus and Nasal Specialists of Louisiana
- Piedmont ENT Associates
- Thomas Jefferson University
- Fort Worth ENT
- ENT and Allergy Associates of Texas
- HNO-ZENTRUM am Kudamm
- Universitatsklinikum Carl Gustav Carus Dresden
- Facharzt für Hals- Nasen- und Ohrenkrankheiten Allergologie Plastische Operationen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RhinAer ARC Stylus Treatment
Arm Description
The RhinAer procedure will be performed in the study clinic using the RhinAer Stylus and Aerin Console. The RhinAer Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants will have both nostrils treated in the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve.
Outcomes
Primary Outcome Measures
Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS)
The TNSS is an instrument used to collect patient self-rated severity of nasal symptoms originally comprised of 3 symptoms (nasal obstruction, itching/sneezing and secretion/runny nose) that has been widely adapted to include 4 nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. The patient rates 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) on the following 4-point scale:
0 = absent symptoms (no sign/symptom is evident)
1 = mild symptoms (sign/symptom present, but minimal awareness; easily tolerated)
2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable)
3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping).
The total score is the sum of the 4 nasal symptoms.
A low score indicates lower symptoms, a higher score indicates more symptoms.
Secondary Outcome Measures
30% Improvement in Reflective Total Nasal Symptoms Score (rTNSS)
The TNSS is an instrument used to collect patient self-rated severity of nasal symptoms. The patient rates 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) on the following 4-point scale:
0 = absent symptoms (no sign/symptom is evident)
1 = mild symptoms (sign/symptom present, but minimal awareness; easily tolerated)
2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable)
3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping).
The total score is the sum of the 4 nasal symptoms.
A low score indicates lower symptoms, a higher score indicates more symptoms.
Improvement indicates if the score at 3 months is lower than at Baseline.
Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (RQLQ)
The Rhinoconjuctivitis Quality of Life Questionnaire is a well-established, validated, and the most frequently used rhinoconjuctivitis disease-specific instrument. The MiniRQLQ, to be used in this study, was developed and validated to further facilitate ease of use and efficiency by reducing the number of questions to 14.
The instrument consists of 14 questions across 5 domains (activity limitations (n=3), practical problems (n=2), nose symptoms (n=3), eye symptoms (n=3), and other symptoms (n=3)). Responses are based on a 1-week recall and provided on a 7-point scale:
0 = not troubled
1 = hardly troubled at all
2 = somewhat troubled
3 = moderately troubled
4 = quite a bit troubled
5 = very troubled
6 = extremely troubled.
The total or overall MiniRQLQ score is the mean of the 14 responses and the domain scores are the mean of the questions in each domain.
Device Related Adverse Events
Evaluate profile by characterizing the type and frequency of adverse events reported at or following the study procedure an throughout the follow up period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04614324
Brief Title
A Study of RhinAer ARC Stylus for Treating Chronic Rhinitis (RELIEF)
Acronym
RELIEF
Official Title
A Prospective, Open Label, Multi-Center Study Using the RhinAer Procedure for Treatment of Subjects Suffering With Chronic Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
August 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerin Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Post-market study to continue to evaluate the effectiveness of the RhinAer ARC Stylus for chronic rhinitis.
Detailed Description
Prospective, Open Label, Multicenter Study of the Aerin Medical RhinAer® ARC Stylus for Chronic Rhinitis to continue to evaluate the effectiveness of the RhinAer® ARC Stylus for treating the posterior nasal nerve area to improve symptoms in adults diagnosed with chronic rhinitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Active treatment for all subject enrolling prospectively
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RhinAer ARC Stylus Treatment
Arm Type
Experimental
Arm Description
The RhinAer procedure will be performed in the study clinic using the RhinAer Stylus and Aerin Console. The RhinAer Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants will have both nostrils treated in the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve.
Intervention Type
Device
Intervention Name(s)
RhinAer ARC Stylus
Intervention Description
The RhinAer procedure incorporates use of the RhinAer Stylus (Model FG815), which is a cleared (FDA - K192471) disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. RhinAer has CE Marking in EU. The Aerin Console (Model FG226) RF generator with temperature control capable of delivering very low doses of energy was cleared for use in the US (FDA - K162810) and has CE Marking in the EU (CE639608).
Primary Outcome Measure Information:
Title
Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS)
Description
The TNSS is an instrument used to collect patient self-rated severity of nasal symptoms originally comprised of 3 symptoms (nasal obstruction, itching/sneezing and secretion/runny nose) that has been widely adapted to include 4 nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. The patient rates 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) on the following 4-point scale:
0 = absent symptoms (no sign/symptom is evident)
1 = mild symptoms (sign/symptom present, but minimal awareness; easily tolerated)
2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable)
3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping).
The total score is the sum of the 4 nasal symptoms.
A low score indicates lower symptoms, a higher score indicates more symptoms.
Time Frame
Baseline and 3 months post study procedure
Secondary Outcome Measure Information:
Title
30% Improvement in Reflective Total Nasal Symptoms Score (rTNSS)
Description
The TNSS is an instrument used to collect patient self-rated severity of nasal symptoms. The patient rates 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) on the following 4-point scale:
0 = absent symptoms (no sign/symptom is evident)
1 = mild symptoms (sign/symptom present, but minimal awareness; easily tolerated)
2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable)
3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping).
The total score is the sum of the 4 nasal symptoms.
A low score indicates lower symptoms, a higher score indicates more symptoms.
Improvement indicates if the score at 3 months is lower than at Baseline.
Time Frame
Baseline and 3 months post study procedure
Title
Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (RQLQ)
Description
The Rhinoconjuctivitis Quality of Life Questionnaire is a well-established, validated, and the most frequently used rhinoconjuctivitis disease-specific instrument. The MiniRQLQ, to be used in this study, was developed and validated to further facilitate ease of use and efficiency by reducing the number of questions to 14.
The instrument consists of 14 questions across 5 domains (activity limitations (n=3), practical problems (n=2), nose symptoms (n=3), eye symptoms (n=3), and other symptoms (n=3)). Responses are based on a 1-week recall and provided on a 7-point scale:
0 = not troubled
1 = hardly troubled at all
2 = somewhat troubled
3 = moderately troubled
4 = quite a bit troubled
5 = very troubled
6 = extremely troubled.
The total or overall MiniRQLQ score is the mean of the 14 responses and the domain scores are the mean of the questions in each domain.
Time Frame
Baseline and 3 months post study procedure
Title
Device Related Adverse Events
Description
Evaluate profile by characterizing the type and frequency of adverse events reported at or following the study procedure an throughout the follow up period
Time Frame
Baseline and 3 months post study procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 to 85 years (inclusively).
Willing and able to provide informed consent.
Willing and able to comply with the subject-specific requirements outlined in the Study Protocol.
Seeking treatment for chronic rhinitis symptoms of at least 6 months duration and willing to undergo an office-based procedure.
Moderate to severe symptoms of rhinorrhea (rTNSS rating of 2 or 3 for rhinorrhea).
Mild to severe symptoms of nasal congestion (rTNSS rating of 1, 2 or 3 for congestion).
rTNSS ≥ 6.
Exclusion Criteria:
Anatomic obstructions that in the investigator's opinion limit access to the posterior nasal passage.
Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery or injury.
Active nasal or sinus infection.
History of significant dry eye.
History of any of the following: chronic epistaxis, documented episodes of significant nose bleeds in the past 3 months, rhinitis medicamentosa, head or neck irradiation.
Have rhinitis symptoms only on a seasonal basis due to allergies.
Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session.
Known or suspected to be pregnant or is lactating.
Participating in another clinical research study.
Has any condition that predisposes to excessive bleeding.
Is taking anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be discontinued before the procedure.
Has previous procedure or surgery for chronic rhinitis.
Other medical conditions which in the opinion of the investigator would predispose the subject to poor wound healing, increased surgical risk, or poor compliance with the requirements of the study.
Facility Information:
Facility Name
Arizona Desert ENT Specialists
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85395
Country
United States
Facility Name
Sacramento ENT
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
ENT Associates of South Florida
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
ENT and Allergy Associates of Florida
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Florida ENT and Allergy
City
Tampa
State/Province
Florida
ZIP/Postal Code
33619
Country
United States
Facility Name
Chicago Nasal and Sinus Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Advanced ENT and Allergy
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40220
Country
United States
Facility Name
Baton Rouge General / Sinus and Nasal Specialists of Louisiana
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Piedmont ENT Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Fort Worth ENT
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76109
Country
United States
Facility Name
ENT and Allergy Associates of Texas
City
McKinney
State/Province
Texas
ZIP/Postal Code
75070
Country
United States
Facility Name
HNO-ZENTRUM am Kudamm
City
Berlin
Country
Germany
Facility Name
Universitatsklinikum Carl Gustav Carus Dresden
City
Dresden
Country
Germany
Facility Name
Facharzt für Hals- Nasen- und Ohrenkrankheiten Allergologie Plastische Operationen
City
Göttingen
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No data collected will be shared with other researchers participating in the study
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/35818709/
Description
Clinical and Quality of Life Outcomes Following Temperature-Controlled Radiofrequency Neurolysis of the Posterior Nasal Nerve (RhinAer) for Treatment of Chronic Rhinitis
Learn more about this trial
A Study of RhinAer ARC Stylus for Treating Chronic Rhinitis (RELIEF)
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