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The purpose of this study is to compare the RhinAer procedure with radiofrequency (RF) energy to sham procedure for treatment of chronic rhinitis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RhinAer Treatment | Active Comparator | 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 |
|
| Control Treatment | Sham Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RhinAer Stylus | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Stolovitzky, MD | ENT of Georgia North | Principal Investigator |
| Mas Takashima, MD | The Sinus Center at Houston Methodist Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sacramento ENT (DaVinci Research) | Roseville | California | 95661 | United States | ||
| Breathe Clear Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34527852 | Result | 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. | |
| 35714267 | Result | 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. |
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There was no wash out or run in for this study
Participants were recruited based on physician referral at X academic medical centers and clinics between July 30, 2020 and December 29, 2020. The first participant was enrolled on July 31, 2020 and the last participant was enrolled in December 28,2020
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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. |
| FG001 | 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). 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Enrollment |
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| Crossover Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Treatment | Subjects randomized to receive the Rhinaer procedure |
| BG001 | Sham Control | Subjects randomized to receive the Sham Procedure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 3 months visit following the study procedure. |
|
3 months
AE- any untoward medical occurrence in a subject SAE-an AE that: led to death, led to serious deterioration in the health, resulted in a life-threatening illness or injury, resulted in permanent impairment of body structure or body function, required hospitalization or prolongation of existing hospitalization, resulted in medical or surgical intervention to prevent permanent impairment, led to fetal distress, fetal death, a congenital abnormality, or birth defect
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal Bleeding | Injury, poisoning and procedural complications | ISO 14155, ICH-GCP | Systematic Assessment | Nasal Bleeding |
Patients with a predisposition to poor wound healing were excluded from this trial, and therefore, the results may not be applicable to this patient population. Investigators were not blinded. The rTNSS used in endpoint evaluation was reported by the blinded patient, mitigating the risk of bias. Pain VAS was completed by the blinded patients. Allergy testing not required and relative efficacy by rhinitis subtype could not be compared. Medication use was not controlled
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Manager of Clinical Operations | Aerin Medical | 312-888-0441 | tdang@aerinmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2021 | Aug 4, 2022 | Prot_SAP_000.pdf |
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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.
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Participant will be blinded to the study arm they are assigned to.
|
| Sham | Device | 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). |
|
| Change from Baseline to 3 months following the study procedure. |
| 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. |
| 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. |
| Torrance |
| California |
| 90503 |
| United States |
| ENT and Allergy Associates of Florida | Plantation | Florida | 33324 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| Piedmont ENT | Atlanta | Georgia | 30309 | United States |
| Rush University | Chicago | Illinois | 60612 | United States |
| Madison ENT | New York | New York | 10016 | United States |
| University of Cincinnati College of Medicine | Cincinnati | Ohio | 45267 | United States |
| Vanderbilt Asthma, Sinus & Allergy Program | Nashville | Tennessee | 37232 | United States |
| Texas Healthcare | Fort Worth | Texas | 76104 | United States |
| Fredericksburg ENT | Fredericksburg | Texas | 78624 | United States |
| ENT Associates of Texas (ENTtex) | McKinney | Texas | 75070 | United States |
| Ogden Clinic | Ogden | Utah | 84403 | United States |
| 38266636 | Result | 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 Rhinol. 2024 Jul;14(7):1182-1194. doi: 10.1002/alr.23315. Epub 2024 Jan 24. |
| 40183781 | Result | Stolovitzky JP, Ow RA, Silvers SL, Tajudeen BA, McDuffie CM, Dean M, Sedaghat AR, Phillips K, Takashima M. 3-Year Outcomes of Temperature-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve in Patients With Chronic Rhinitis. Int Forum Allergy Rhinol. 2025 Sep;15(9):915-925. doi: 10.1002/alr.23577. Epub 2025 Apr 4. |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Nasal Exam Turbinate Enlargement | Count of Participants | Participants |
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| Nasal Exam Nasal Polyps | Count of Participants | Participants |
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| Prior Nasal Surgery | Count of Participants | Participants |
|
| rTNSS | TNSS is an instrument used to collect patient self-rated severity of nasal symptoms. The FDA cites this as a preferred measure of efficacy in trials of drug treatments for rhinitis. 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. | Mean | Standard Deviation | rTNSS Score |
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| Medication Use - Antihistamines | Count of Participants | Participants |
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| Medication Use - Decongestants | Count of Participants | Participants |
|
| Medication Use - Oral leukotriene inhibitors | Count of Participants | Participants |
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| Medication use - Intranasal steroid sprays | Count of Participants | Participants |
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| Medication Use -Intranasal anticholinergic sprays | Count of Participants | Participants |
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| OG001 | Sham Control | Subject randomized who received Sham Treatment |
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| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Change from Baseline to 3 months following the study procedure. |
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| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Change from Baseline to 12 months following the study procedure. |
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|
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| 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. | Posted | Count of Participants | Participants | At or following the study procedure up to to 3 months. |
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| Other Pre-specified | 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. | Posted | Number | participants | Baseline, 1 month, 3 months and 6 months following the study procedure |
|
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| 0 |
| 77 |
| 0 |
| 77 |
| 7 |
| 77 |
| EG001 | 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). 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). | 0 | 39 | 0 | 39 | 1 | 39 |
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| Nasal Congestion | Injury, poisoning and procedural complications | ISO 14155, ICH-GCP | Systematic Assessment | Nasal Congestion |
|
| Headache | Nervous system disorders | ISO 14155, ICH-GCP | Systematic Assessment | Headache |
|
| Vasovagal Reaction | Nervous system disorders | ISO 14155, ICH-GCP | Systematic Assessment | Vasovagal Reaction |
|
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| Mild nasal bleeding immediate post procedure |
|