Adults 22 to 75, any sex, with Chronic Rhinitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Reflective Total Nasal Symptom Score (rTNSS)Primary· Comparison of scores at Baseline and 12 weeks post procedure
Mean change in Reflective Total Nasal Symptoms Score (rTNSS) from baseline to 12 weeks post-study procedure. Improvement (12 week score - baseline score) is signified by a negative value.
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 the rTNSS total score from Bas
Group
Value
95% CI
InSeca Stylus Treatment Group
-5.1
± 2.6
Percentage of Participants With Treatment Related Adverse Events (Safety)Primary· At or following the study procedure, and up to the final study visit at 1 year.
Characterization of the type and frequency of treatment-related adverse events reported during or following the study procedure. Subjects were asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. Each event was documented and identified as to its relationship and level of relatedness to the study device and/or study procedure.
This measure includes any subject who experienced at least one event considered definitely, probably, or possibly related to the device or procedure.
Group
Value
95% CI
InSeca Stylus Treatment Group
8
rTNSS Responder RateSecondary· Comparison of scores at Baseline and 12 weeks post 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 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.
Subjects who showed at least a 1 point improvement (decrease) in the reflective Total Nasal Symptom Score (rTNSS) were categorized as responders. An overall responder rate of at least 55% was expected.
Group
Value
95% CI
InSeca Stylus Treatment Group
46
Change in rTNSS Over TimeSecondary· Baseline to each Follow Up Visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure.
Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients report their symptoms reflected or felt over the last 12 hours. Total scores range from 0 to 12. A higher score indicates increased symptom severity.
The mean change in the rTNSS total score from Baseline to each follow up visit: 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure will be recorded.
Group
Value
95% CI
Treatment Group - Baseline
8.5
± 1.8
Treatment Group - 2 Week Data
4.8
± 2.4
Treatment Group - 4 Week Data
3.6
± 2.1
Treatment Group - 12 Week Data
3.4
± 2.3
Treatment Group - 26 Week Data
3.3
± 2.1
Treatment Group - 52 Week Data
3.6
± 2.3
Change in rTNSS Individual Nasal Symptom Component Scores Over TimeSecondary· Baseline to each Follow Up visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure
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.
Scores from each of the four components of the questionnaire (rhinorrhea, nasal congestion, nasal itching, and sneezing) will be evaluated at each follow up visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure. Individual component scores can r
Rhinorrhea
Group
Value
95% CI
Treatment Group - Baseline
2.5
± 0.5
Treatment Group - 2 Week Data
1.6
± 0.9
Treatment Group - 4 Week Data
1.2
± 0.8
Treatment Group - 12 Week Data
1.0
± 0.7
Treatment Group - 26 Week Data
0.9
± 0.8
Treatment Group - 52 Week Data
1.1
± 0.8
Nasal Congestion
Group
Value
95% CI
Treatment Group - Baseline
2.5
± 0.6
Treatment Group - 2 Week Data
1.5
± 1.0
Treatment Group - 4 Week Data
1.1
± 0.8
Treatment Group - 12 Week Data
1.1
± 0.8
Treatment Group - 26 Week Data
1.1
± 0.8
Treatment Group - 52 Week Data
1.2
± 1.0
Nasal Itching
Group
Value
95% CI
Treatment Group - Baseline
1.7
± 0.9
Treatment Group - 2 Week Data
0.7
± 0.8
Treatment Group - 4 Week Data
0.4
± 0.6
Treatment Group - 12 Week Data
0.5
± 0.7
Treatment Group - 26 Week Data
0.5
± 0.7
Treatment Group - 52 Week Data
0.5
± 0.7
Sneezing
Group
Value
95% CI
Treatment Group - Baseline
1.9
± 0.8
Treatment Group - 2 Week Data
1.0
± 0.7
Treatment Group - 4 Week Data
0.8
± 0.6
Treatment Group - 12 Week Data
0.9
± 0.8
Treatment Group - 26 Week Data
0.8
± 0.7
Treatment Group - 52 Week Data
0.8
± 0.8
Response on Aerin Quality-of-Life (QOL) Assessment ItemsSecondary· The QOL was to be completed by the subject at baseline prior to the treatment procedure, and at the 12 week, 26 week and 52 week visits post procedure.
This Quality-of-Life (QOL) instrument is a 9-item patient self-reported questionnaire developed by Aerin Medical to gain understanding of the impact of chronic rhinitis on daily activities, feelings, symptoms and medication use. Each item had 5 possible answers to convey the following responses: very positive, positive, neutral, negative and very negative.
Section 1 asks "Please indicate how often you experience the following" for 6 items. For items 1, 3, 4 and 5, those who answered "never/rarely" were considered to have a positive (favorable) response. For questions 2 and 6, those who answer
Section 1, Item 1: Difficulty falling asleep
Group
Value
95% CI
Treatment Group - Baseline
5
Treatment Group - 12 Week Data
23
Treatment Group - 26 Week Data
26
Treatment Group - 52 Week Data
28
Treatment Group - Baseline
41
Treatment Group - 12 Week Data
25
Treatment Group - 26 Week Data
22
Treatment Group - 52 Week Data
19
Section 1, Item 2: Good sleep throughout the night
Group
Value
95% CI
Treatment Group - Baseline
11
Treatment Group - 12 Week Data
28
Treatment Group - 26 Week Data
28
Treatment Group - 52 Week Data
22
Treatment Group - Baseline
35
Treatment Group - 12 Week Data
20
Treatment Group - 26 Week Data
20
Treatment Group - 52 Week Data
25
Section 1, Item 3: Feeling fatigued during the day
Group
Value
95% CI
Treatment Group - Baseline
3
Treatment Group - 12 Week Data
17
Treatment Group - 26 Week Data
14
Treatment Group - 52 Week Data
14
Treatment Group - Baseline
43
Treatment Group - 12 Week Data
31
Treatment Group - 26 Week Data
34
Treatment Group - 52 Week Data
33
Section 1, Item 4: Feelings of frustration/restlessness/irritability
Group
Value
95% CI
Treatment Group - Baseline
7
Treatment Group - 12 Week Data
30
Treatment Group - 26 Week Data
26
Treatment Group - 52 Week Data
29
Treatment Group - Baseline
39
Treatment Group - 12 Week Data
18
Treatment Group - 26 Week Data
22
Treatment Group - 52 Week Data
18
Section 1, Item 5: Feelings of embarrassment or self-consciousness
Group
Value
95% CI
Treatment Group - Baseline
10
Treatment Group - 12 Week Data
38
Treatment Group - 26 Week Data
31
Treatment Group - 52 Week Data
33
Treatment Group - Baseline
36
Treatment Group - 12 Week Data
10
Treatment Group - 26 Week Data
17
Treatment Group - 52 Week Data
14
Section 1, Item 6: Having a good sense of overall well-being
Group
Value
95% CI
Treatment Group - Baseline
24
Treatment Group - 12 Week Data
36
Treatment Group - 26 Week Data
38
Treatment Group - 52 Week Data
40
Treatment Group - Baseline
22
Treatment Group - 12 Week Data
12
Treatment Group - 26 Week Data
10
Treatment Group - 52 Week Data
7
Section 2, Item 1: Oral medications
Group
Value
95% CI
Treatment Group - Baseline
10
Treatment Group - 12 Week Data
20
Treatment Group - 26 Week Data
17
Treatment Group - 52 Week Data
19
Treatment Group - Baseline
36
Treatment Group - 12 Week Data
28
Treatment Group - 26 Week Data
31
Treatment Group - 52 Week Data
28
Section 2, Item 2: Nasal sprays
Group
Value
95% CI
Treatment Group - Baseline
9
Treatment Group - 12 Week Data
24
Treatment Group - 26 Week Data
26
Treatment Group - 52 Week Data
20
Treatment Group - Baseline
37
Treatment Group - 12 Week Data
24
Treatment Group - 26 Week Data
22
Treatment Group - 52 Week Data
27
Adverse events — posted to ClinicalTrials.gov
Time frame: From study procedure through 52-week evaluation.
Reporting threshold: 4%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Aerin Medical
Last refreshed: 16 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03727347.