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A Study of RhinAer ARC Stylus for Treating Chronic Rhinitis (RELIEF) (RELIEF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04614324
Recruitment Status : Active, not recruiting
First Posted : November 4, 2020
Last Update Posted : October 18, 2021
Sponsor:
Information provided by (Responsible Party):
Aerin Medical

Brief Summary:
Post-market study to continue to evaluate the effectiveness of the RhinAer ARC Stylus for chronic rhinitis.

Condition or disease Intervention/treatment Phase
Chronic Rhinitis Device: RhinAer ARC Stylus Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Active treatment for all subject enrolling prospectively
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open Label, Multi-Center Study Using the RhinAer Procedure for Treatment of Subjects Suffering With Chronic Rhinitis
Actual Study Start Date : October 5, 2020
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : August 30, 2024

Arm Intervention/treatment
Experimental: RhinAer ARC Stylus 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 both nostrils treated in the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve.
Device: RhinAer ARC Stylus
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 Measures :
  1. Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS) [ Time Frame: Baseline and 3 months post study procedure ]

    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 :
  1. 30% Improvement in Reflective Total Nasal Symptoms Score (rTNSS) [ Time Frame: Baseline and 3 months post study procedure ]

    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.


  2. Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: Baseline and 3 months post study procedure ]

    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.


  3. Device Related Adverse Events [ Time Frame: Baseline and 3 months post study procedure ]
    Evaluate profile by characterizing the type and frequency of adverse events reported at or following the study procedure an throughout the follow up period



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04614324


Locations
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United States, Arizona
Arizona Desert ENT Specialists
Goodyear, Arizona, United States, 85395
United States, California
Sacramento ENT
Roseville, California, United States, 95661
University of California, San Francisco
San Francisco, California, United States, 94115
United States, Florida
ENT Associates of South Florida
Boca Raton, Florida, United States, 33487
ENT and Allergy Associates of Florida
Port Saint Lucie, Florida, United States, 34952
Florida ENT and Allergy
Tampa, Florida, United States, 33619
United States, Illinois
Chicago Nasal and Sinus Center
Chicago, Illinois, United States, 60602
University of Illinois, Chicago
Chicago, Illinois, United States, 61801
United States, Kentucky
Advanced ENT and Allergy
Louisville, Kentucky, United States, 40220
United States, Louisiana
Baton Rouge General / Sinus and Nasal Specialists of Louisiana
Baton Rouge, Louisiana, United States, 70809
United States, North Carolina
Piedmont ENT Associates
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Fort Worth ENT
Fort Worth, Texas, United States, 76109
ENT and Allergy Associates of Texas
McKinney, Texas, United States, 75070
Sponsors and Collaborators
Aerin Medical
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Responsible Party: Aerin Medical
ClinicalTrials.gov Identifier: NCT04614324    
Other Study ID Numbers: CTP1056
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: October 18, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data collected will be shared with other researchers participating in the study

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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:
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Rhinitis
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases