Trial Outcomes & Findings for RhinAer Procedure for Treatment of Chronic Rhinitis Study (NCT NCT04533438)
NCT ID: NCT04533438
Last Updated: 2025-05-02
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
116 participants
Primary outcome timeframe
3 months visit following the study procedure.
Results posted on
2025-05-02
Participant Flow
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
There was no wash out or run in for this study
Participant milestones
| Measure |
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.
|
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).
|
|---|---|---|
|
Initial Enrollment
STARTED
|
77
|
39
|
|
Initial Enrollment
COMPLETED
|
77
|
39
|
|
Initial Enrollment
NOT COMPLETED
|
0
|
0
|
|
Crossover Period
STARTED
|
0
|
39
|
|
Crossover Period
COMPLETED
|
0
|
28
|
|
Crossover Period
NOT COMPLETED
|
0
|
11
|
Reasons for withdrawal
| Measure |
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.
|
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).
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|---|---|---|
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Crossover Period
Did not meet Eligibility to Crossover
|
0
|
11
|
Baseline Characteristics
RhinAer Procedure for Treatment of Chronic Rhinitis Study
Baseline characteristics by cohort
| Measure |
Active Treatment
n=77 Participants
Subjects randomized to receive the Rhinaer procedure
|
Sham Control
n=39 Participants
Subjects randomized to receive the Sham Procedure
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 14.8 • n=99 Participants
|
57.8 years
STANDARD_DEVIATION 14.4 • n=107 Participants
|
57.5 years
STANDARD_DEVIATION 14.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Nasal Exam Turbinate Enlargement
|
16 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Nasal Exam Nasal Polyps
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Prior Nasal Surgery
|
27 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
rTNSS
|
8.3 rTNSS Score
STANDARD_DEVIATION 1.9 • n=99 Participants
|
8.2 rTNSS Score
STANDARD_DEVIATION 1.8 • n=107 Participants
|
8.25 rTNSS Score
STANDARD_DEVIATION 1.85 • n=206 Participants
|
|
Medication Use - Antihistamines
|
56 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Medication Use - Decongestants
|
22 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Medication Use - Oral leukotriene inhibitors
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Medication use - Intranasal steroid sprays
|
34 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Medication Use -Intranasal anticholinergic sprays
|
19 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months visit following the study procedure.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
Outcome measures
| Measure |
Active Treatment
n=77 Participants
Subject randomized who received Rhinaer Treatment
|
Sham Control
n=39 Participants
Subject randomized who received Sham Treatment
|
|---|---|---|
|
Reflective Total Nasal Symptom Score (rTNSS) Responder Rate
|
52 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Active Treatment
n=77 Participants
Subject randomized who received Rhinaer Treatment
|
Sham Control
n=39 Participants
Subject randomized who received Sham Treatment
|
|---|---|---|
|
Reflective Total Nasal Symptom Score (rTNSS) Mean Change
|
-3.6 score on a scale
Interval -4.2 to -3.0
|
-2.2 score on a scale
Interval -3.2 to -1.3
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 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.
Outcome measures
| Measure |
Active Treatment
n=88 Participants
Subject randomized who received Rhinaer Treatment
|
Sham Control
Subject randomized who received Sham Treatment
|
|---|---|---|
|
Reflective Total Nasal Symptom Score (rTNSS) Mean Change
|
-4.8 score on a scale
Interval -5.5 to -4.1
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Active Treatment
n=77 Participants
Subject randomized who received Rhinaer Treatment
|
Sham Control
n=39 Participants
Subject randomized who received Sham Treatment
|
|---|---|---|
|
Percentage of Participants With Treatment Related Events (Safety)
Severe Nasal Soreness/Pain
|
1 Participants
|
0 Participants
|
|
Percentage of Participants With Treatment Related Events (Safety)
Increased Nasal Congestion at 1 month
|
1 Participants
|
0 Participants
|
|
Percentage of Participants With Treatment Related Events (Safety)
Mild nasal bleeding immediate post procedure
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 1 month, 3 months and 6 months following the study procedureThe 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.
Outcome measures
| Measure |
Active Treatment
n=77 Participants
Subject randomized who received Rhinaer Treatment
|
Sham Control
n=39 Participants
Subject randomized who received Sham Treatment
|
|---|---|---|
|
Nasal Status Assessment
Significant Dry Eye
|
1 participants
|
0 participants
|
|
Nasal Status Assessment
Soreness, Pain
|
3 participants
|
4 participants
|
Adverse Events
RhinAer Treatment
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Control Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RhinAer Treatment
n=77 participants at risk
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.
|
Control Treatment
n=39 participants at risk
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).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Nasal Bleeding
|
2.6%
2/77 • Number of events 2 • 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
|
0.00%
0/39 • 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
|
|
Injury, poisoning and procedural complications
Nasal Congestion
|
3.9%
3/77 • Number of events 3 • 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
|
0.00%
0/39 • 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
|
|
Nervous system disorders
Headache
|
1.3%
1/77 • Number of events 1 • 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
|
2.6%
1/39 • Number of events 1 • 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
|
|
Nervous system disorders
Vasovagal Reaction
|
1.3%
1/77 • Number of events 1 • 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
|
0.00%
0/39 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place