RHINTRAC: RhinAer Procedure for Treatment of Chronic Rhinitis Study

Sponsor
Aerin Medical (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04533438
Collaborator
(none)
120
20
2
32
6
0.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: RhinAer Stylus
  • Device: Sham
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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.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:
Single (Participant)
Masking Description:
Participant will be blinded to the study arm they are assigned to.
Primary Purpose:
Treatment
Official Title:
The RhinAer Procedure for Treatment of CHronic RhInitis - A Prospective, MulticeNter Randomized ConTrolled TRial Comparing RhinAer to Sham Control (RHINTRAC)
Actual Study Start Date :
Jul 31, 2020
Actual Primary Completion Date :
Apr 9, 2021
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: RhinAer Treatment

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

Device: RhinAer Stylus
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.

Sham Comparator: Control Treatment

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).

Device: Sham
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).

Outcome Measures

Primary Outcome Measures

  1. Reflective Total Nasal Symptom Score (rTNSS) Responder Rate [3 months visit following the study procedure.]

    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 responder rate defined as at least a 1 point improvement (decrease) in the rTNSS score. An overall responder rate of at least 55% is expected in the rTNSS total score from Baseline to 3 month follow up visit.

Secondary Outcome Measures

  1. Reflective Total Nasal Symptom Score (rTNSS) Mean Change [Change from Baseline to 3 months following the study procedure.]

    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.

  2. Percentage of Participants with Treatment Related Events (Safety) [At or following the study procedure up to to 3 months.]

    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.

Other Outcome Measures

  1. Percentage of Participants with Treatment Related Events (Safety) [At or following the study procedure up to to the final study visit of 24 months.]

    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.

  2. Nasal Status Assessment [Baseline, 1 month, 3 months and 6 months following the study procedure]

    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.

  3. Visual Analog Scale (VAS) for Pain [The VAS Pain will be completed by the subjects at the 1 month and 3 months visits following the study procedure]

    The Visual Analog Scale (VAS) is a self reported score of pain felt during the treatment session and pain as it exists at specified visits post procedure. Patients will mark where they feel their pain exists on a 10 cm line. A score of 0 = No Pain and a score of 10 = Worst Pain Imaginable. Pain scores will be summarized for pain reported immediately post procedure and at the 1 month and 3 month visits post procedure.

  4. Reflective Total Nasal Symptom Score (rTNSS) Mean [At Baseline, and 3 months, 6 months, 12 months and 24 months following the study procedure]

    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 rTNSS score at Baseline and 3 months, 6 months, 12 months and 24 months after the procedure.

  5. Reflective Total Nasal Symptom Score (rTNSS) Mean Change [Mean change from Baseline to 3 months, 6 months, 12 months and 24 months following the study procedure]

    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 rTNSS score from Baseline to 3 months, 6 months, 12 months and 24 months after the procedure.

  6. Reflective Total Nasal Symptom Score (rTNSS) Individual Nasal Symptom Scores (rhinorrhea, nasal congestion, nasal itching, and sneezing) [Baseline and 3 months, 6 months, 12 months and 24 months following the study procedure]

    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. This study will evaluate rTNSS Individual Nasal Symptom Scores (rhinorrhea, nasal congestion, nasal itching, and sneezing) will be evaluated at baseline and the 3-, 6-, 12-, and 24-month follow-up following the procedure.

  7. Reflective Total Nasal Symptom Score (rTNSS) Responder Rate [3 months, 6 months, 12 months and 24 months following the study procedure]

    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. rTNSS responder rate defined of at least a 1 point improvement (decrease) in the rTNSS score. This study will measure the proportion of responders based on improvement in rTNSS at the 3-, 6-, 12-, and 24-month following the procedure

  8. Other Rhinitis Symptoms [Baseline, 3 months, 6 months, 12 months and 24 months following the study procedure]

    Other rhinitis symptoms - current symptoms of cough and postnasal drip or excess mucous in the throat, rated on a 0 to 3 scale from 'No symptoms' to 'Severe symptoms' will be evaluated.

  9. mini RQLQ (rhinitis quality of life questionnaire) Questionnaire Mean Score [Baseline, 3 months, 6 months, 12 months and 24 months following the study procedure]

    The RQLQ 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.

  10. mini RQLQ (rhinitis quality of life questionnaire) Questionnaire Mean Change [Change from Baseline to 3 months, 6 months, 12 months and 24 months following the study procedure]

    The RQLQ 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.

  11. Subject Satisfaction Survey [3 months, 6 months, 12 months and 24 months following the study procedure]

    Subject Satisfaction Survey is a patient self reported questionnaire to assess patient acceptance of the treatment procedure and results. 5 questions are asked on a 10-point scale where a score of 1 is a poor acceptance of the procedure and 10 is a positive acceptance.

  12. Chronic Rhinitis Symptom "as needed" medication [3 months, 6 months, 12 months and 24 months following the study procedure]

    Change in amount of "as needed" medication/device use for chronic rhinitis symptoms - Self-reported assessment of an increase, no change, or decrease in medications and/or devices being used for treatment of symptoms compared to use prior to the procedure administered at the 3-, 6-, 12-, and 24-month follow-up evaluations.

  13. Concomitant Medication Usage [Baseline, 1 month, 3 months, 6 months, 12 months and 24 months following the study procedure]

    Patients will report any medication they are using at each study visit. Medication information will be summarized and reviewed to understand type, dose, frequency, duration and relation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Age 18 to 85 years (inclusively).

  2. Willing and able to provide informed consent.

  3. Willing and able to comply with the subject-specific requirements outlined in the Study Protocol.

  4. Seeking treatment for chronic rhinitis symptoms of at least 6 months duration and willing to undergo an office-based procedure.

  5. Moderate to severe symptoms of rhinorrhea (rTNSS rating of 2 or 3 for rhinorrhea).

  6. Mild to severe symptoms of nasal congestion (rTNSS rating of 1, 2 or 3 for congestion).

  7. rTNSS ≥ 6.

Exclusion Criteria:
  1. Anatomic obstructions that in the investigator's opinion limit access to the posterior nasal passage.

  2. Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery or injury.

  3. Active nasal or sinus infection.

  4. History of significant dry eye.

  5. 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.

  6. Have rhinitis symptoms only on a seasonal basis due to allergies.

  7. Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session.

  8. Known or suspected to be pregnant or is lactating.

  9. Participating in another clinical research study.

  10. Has any condition that predisposes to excessive bleeding.

  11. Is taking anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be discontinued before the procedure.

  12. Has previous procedure or surgery for chronic rhinitis.

  13. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sacramento ENT (DaVinci Research) Roseville California United States 95661
2 Breathe Clear Institute Torrance California United States 90503
3 Otolaryngology Consultants, PA Boynton Beach Florida United States 33437
4 ENT and Allergy Associates of Florida Fort Lauderdale Florida United States 33301
5 ENT and Allergy Associates of Florida Plantation Florida United States 33324
6 University of South Florida Tampa Florida United States 33612
7 Piedmont ENT Atlanta Georgia United States 30309
8 ENT of Georgia Atlanta Georgia United States 30342
9 Rush University Chicago Illinois United States 60612
10 BreatheAmerica Albuquerque New Mexico United States 87109
11 Madison ENT New York New York United States 10016
12 Charlotte Eyes Ears Nose Throat Associates (CEENTA) Concord North Carolina United States 28025
13 University of Cincinnati College of Medicine Cincinnati Ohio United States 45267
14 Bethlehem ENT Bethlehem Pennsylvania United States 18017
15 Vanderbilt Asthma, Sinus & Allergy Program Nashville Tennessee United States 37232
16 Texas Healthcare Fort Worth Texas United States 76104
17 Fredericksburg ENT Fredericksburg Texas United States 78624
18 Houston Methodist Hospital Houston Texas United States 77030
19 ENT Associates of Texas (ENTtex) McKinney Texas United States 75070
20 Ogden Clinic Ogden Utah United States 84403

Sponsors and Collaborators

  • Aerin Medical

Investigators

  • Principal Investigator: Pablo Stolovitzky, MD, ENT of Georgia North
  • Principal Investigator: Mas Takashima, MD, The Sinus Center at Houston Methodist Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aerin Medical
ClinicalTrials.gov Identifier:
NCT04533438
Other Study ID Numbers:
  • CTP1004
First Posted:
Aug 31, 2020
Last Update Posted:
Jul 29, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2022