Back to resultsRhinAer Procedure for Treatment of Chronic Rhinitis Study (RHINTRAC)
Primary Purpose
Chronic Rhinitis
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RhinAer Stylus
Sham
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
- Sacramento ENT (DaVinci Research)
- Breathe Clear Institute
- Otolaryngology Consultants, PA
- ENT and Allergy Associates of Florida
- ENT and Allergy Associates of Florida
- University of South Florida
- Piedmont ENT
- ENT of Georgia
- Rush University
- BreatheAmerica
- Madison ENT
- Charlotte Eyes Ears Nose Throat Associates (CEENTA)
- University of Cincinnati College of Medicine
- Bethlehem ENT
- Vanderbilt Asthma, Sinus & Allergy Program
- Texas Healthcare
- Fredericksburg ENT
- Houston Methodist Hospital
- ENT Associates of Texas (ENTtex)
- Ogden Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
RhinAer Treatment
Control 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 the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior turbinate) in both nostrils treated during a single study procedure session. Each nostril will be treated at 1, 2, 3, 4 or 5 nonoverlapping positions depending on the size of the target treatment area. Treatment settings to be used are temperature 60 °C, power 4 watts, treatment time 12 seconds, and cooling time 0 seconds
The control treatment will be performed in the study clinic using the RhinAer Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).
Outcomes
Primary Outcome Measures
Reflective Total Nasal Symptom Score (rTNSS) Responder Rate
TNSS is an instrument used to collect patient self-rated severity of nasal symptoms. 4 Symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) are reported with score of 0/absent; 1/mild; 2/moderate; 3/severe. The total score is the sum of the 4 nasal symptom scores with a maximum TNSS of 12 indicating the most severe symptoms. Treatment Responder based on rTNSS improvement Individual participant success (responder) is defined as at least 30% improvement (decrease) in the rTNSS from baseline.
For this protocol patients had to meet inclusion criteria of rTNSS rating of 2 or 3 for Rhinorrhea; rTNSS rating of 1, 2 or 3 for Congestion; and total rTNSS score >/= 6 at baseline
Secondary Outcome Measures
Reflective Total Nasal Symptom Score (rTNSS) Mean Change
The Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients will report their symptoms reflected or felt over the last 12 hours. Total scores can range from 0 to 12. A higher score indicates increased symptom severity.
This study will measure the mean change in rTNSS from baseline to 3 months after the procedure.
Percentage of Participants With Treatment Related Events (Safety)
Characterizing the type and frequency of adverse events reported. Subjects will be asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. All events will be documented and identified as to its relationship and level of relatedness to the study device and/or study procedure. Date of onset, severity, duration and outcome will be documented.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04533438
Brief Title
RhinAer Procedure for Treatment of Chronic Rhinitis Study
Acronym
RHINTRAC
Official Title
The RhinAer Procedure for Treatment of CHronic RhInitis - A Prospective, MulticeNter Randomized ConTrolled TRial Comparing RhinAer to Sham Control (RHINTRAC)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 31, 2020 (Actual)
Primary Completion Date
April 9, 2021 (Actual)
Study Completion Date
April 1, 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
The purpose of this study is to compare the RhinAer procedure with radiofrequency (RF) energy to sham procedure for treatment of chronic rhinitis.
Detailed Description
The purpose of this study is to compare the RhinAer procedure to treat tissue in the posterior nasal nerve area to improve symptoms in adults diagnosed with chronic rhinitis with a sham procedure that duplicates the actual procedure as closely as possible absent the delivery of radiofrequency (RF) energy to the nasal tissue.
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
Crossover Assignment
Model Description
2:1 site-stratified randomization will be used to allocate participants to either the RhinAer procedure or treatment with the sham (control) procedure. Crossover within 30 days after 3- or 6-month follow-up visit.
Masking
Participant
Masking Description
Participant will be blinded to the study arm they are assigned to.
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RhinAer Treatment
Arm Type
Active Comparator
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 the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior turbinate) in both nostrils treated during a single study procedure session. Each nostril will be treated at 1, 2, 3, 4 or 5 nonoverlapping positions depending on the size of the target treatment area. Treatment settings to be used are temperature 60 °C, power 4 watts, treatment time 12 seconds, and cooling time 0 seconds
Arm Title
Control Treatment
Arm Type
Sham Comparator
Arm Description
The control treatment will be performed in the study clinic using the RhinAer Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).
Intervention Type
Device
Intervention Name(s)
RhinAer Stylus
Intervention 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 the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior turbinate) in both nostrils treated during a single study procedure session.
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
The control treatment will be performed in the study clinic using the RhinAer Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).
Primary Outcome Measure Information:
Title
Reflective Total Nasal Symptom Score (rTNSS) Responder Rate
Description
TNSS is an instrument used to collect patient self-rated severity of nasal symptoms. 4 Symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) are reported with score of 0/absent; 1/mild; 2/moderate; 3/severe. The total score is the sum of the 4 nasal symptom scores with a maximum TNSS of 12 indicating the most severe symptoms. Treatment Responder based on rTNSS improvement Individual participant success (responder) is defined as at least 30% improvement (decrease) in the rTNSS from baseline.
For this protocol patients had to meet inclusion criteria of rTNSS rating of 2 or 3 for Rhinorrhea; rTNSS rating of 1, 2 or 3 for Congestion; and total rTNSS score >/= 6 at baseline
Time Frame
3 months visit following the study procedure.
Secondary Outcome Measure Information:
Title
Reflective Total Nasal Symptom Score (rTNSS) Mean Change
Description
The Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients will report their symptoms reflected or felt over the last 12 hours. Total scores can range from 0 to 12. A higher score indicates increased symptom severity.
This study will measure the mean change in rTNSS from baseline to 3 months after the procedure.
Time Frame
Change from Baseline to 3 months following the study procedure.
Title
Percentage of Participants With Treatment Related Events (Safety)
Description
Characterizing the type and frequency of adverse events reported. Subjects will be asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. All events will be documented and identified as to its relationship and level of relatedness to the study device and/or study procedure. Date of onset, severity, duration and outcome will be documented.
Time Frame
At or following the study procedure up to to 3 months.
Other Pre-specified Outcome Measures:
Title
Nasal Status Assessment
Description
The Nasal Status Assessment is an evaluation, performed by a physician, of 10 specified physical or intranasal findings. Each finding is ranked in severity from Not Present to Severe. Each component of the assessment will be summarized.
Time Frame
Baseline, 1 month, 3 months and 6 months following the 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Stolovitzky, MD
Organizational Affiliation
ENT of Georgia North
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mas Takashima, MD
Organizational Affiliation
The Sinus Center at Houston Methodist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sacramento ENT (DaVinci Research)
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Breathe Clear Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
Otolaryngology Consultants, PA
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
ENT and Allergy Associates of Florida
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33301
Country
United States
Facility Name
ENT and Allergy Associates of Florida
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Piedmont ENT
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
ENT of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Rush University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
BreatheAmerica
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Madison ENT
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Charlotte Eyes Ears Nose Throat Associates (CEENTA)
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Bethlehem ENT
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Vanderbilt Asthma, Sinus & Allergy Program
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Healthcare
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Fredericksburg ENT
City
Fredericksburg
State/Province
Texas
ZIP/Postal Code
78624
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
ENT Associates of Texas (ENTtex)
City
McKinney
State/Province
Texas
ZIP/Postal Code
75070
Country
United States
Facility Name
Ogden Clinic
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34527852
Citation
Stolovitzky JP, Ow RA, Silvers SL, Bikhazi NB, Johnson CD, Takashima M. Effect of Radiofrequency Neurolysis on the Symptoms of Chronic Rhinitis: A Randomized Controlled Trial. OTO Open. 2021 Sep 10;5(3):2473974X211041124. doi: 10.1177/2473974X211041124. eCollection 2021 Jul-Sep.
Results Reference
result
PubMed Identifier
35714267
Citation
Takashima M, Stolovitzky JP, Ow RA, Silvers SL, Bikhazi NB, Johnson CD. Temperature-controlled radiofrequency neurolysis for treatment of chronic rhinitis: 12-month outcomes after treatment in a randomized controlled trial. Int Forum Allergy Rhinol. 2023 Feb;13(2):107-115. doi: 10.1002/alr.23047. Epub 2022 Jul 5.
Results Reference
result
Learn more about this trial
RhinAer Procedure for Treatment of Chronic Rhinitis Study
We'll reach out to this number within 24 hrs