RhinAer Procedure for Treatment of Chronic Rhinitis Study

Chronic Rhinitis Clinical Trial

— RHINTRAC  

Official title:

The RhinAer Procedure for Treatment of CHronic RhInitis - A Prospective, MulticeNter Randomized ConTrolled TRial Comparing RhinAer to Sham Control (RHINTRAC)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04533438
• Other study ID #: CTP1004
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 31, 2020
• Est. completion date: April 1, 2025

Study information

• Verified date: June 2024
• Source: Aerin Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the RhinAer procedure with radiofrequency (RF) energy to sham procedure for treatment of chronic rhinitis.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 116
• Est. completion date: April 1, 2025
• Est. primary completion date: April 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinitis
• Rhinitis

Intervention

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
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).

Locations

Country	Name	City	State
United States	Piedmont ENT	Atlanta	Georgia
United States	Rush University	Chicago	Illinois
United States	University of Cincinnati College of Medicine	Cincinnati	Ohio
United States	Texas Healthcare	Fort Worth	Texas
United States	Fredericksburg ENT	Fredericksburg	Texas
United States	ENT Associates of Texas (ENTtex)	McKinney	Texas
United States	Vanderbilt Asthma, Sinus & Allergy Program	Nashville	Tennessee
United States	Madison ENT	New York	New York
United States	Ogden Clinic	Ogden	Utah
United States	ENT and Allergy Associates of Florida	Plantation	Florida
United States	Sacramento ENT (DaVinci Research)	Roseville	California
United States	University of South Florida	Tampa	Florida
United States	Breathe Clear Institute	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Aerin Medical

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. e — View 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 — View Citation

Takashima M, Stolovitzky JP, Ow RA, Silvers SL, McDuffie CM, Dean M, Sedaghat AR, Tajudeen BA. Temperature-controlled radiofrequency ablation for the treatment of chronic rhinitis: Two-year outcomes from a prospective multicenter trial. Int Forum Allergy — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nasal Status Assessment	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.	Baseline, 1 month, 3 months and 6 months following the study procedure
Primary	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	3 months visit following the study procedure.
Secondary	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.	Change from Baseline to 3 months following the study procedure.
Secondary	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.	Change from Baseline to 12 months following the study procedure.
Secondary	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.	At or following the study procedure up to to 3 months.