Posterior Nasal Nerve (PNN) Rhinitis Study

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 Baseline to 12 week follow up visit

Time frame: Comparison of scores at Baseline and 12 weeks post procedure

Population: The analyzed population excludes one subject who did not complete the rTNSS questionnaire at the 12 week follow-up visit due to oversight.

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.

Time frame: At or following the study procedure, and up to the final study visit at 1 year.

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 range from 0 to 3, with a higher score indicating increased symptom severity.

Time frame: 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.

Time frame: Baseline to each Follow Up Visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure.

Population: 50 subjects were enrolled. 2 week evaluation: 1 subject missed it due to unrelated illness. 4 week evaluation: 1 subject missed it due to travel; 1 other attended the visit but did not complete the questionnaire. 12 week evaluation: All subjects attended but 1 subject did not complete the questionnaire. 26 week evaluation: 2 subjects withdrew from the study prior to the visit. 52 week evaluation: 1 additional subject was lost to follow-up.

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 answered frequently/very frequently were considered to have a positive (favorable) response. Section 2 requests Please indicate how often you use each of the following products to help you with your chronic rhinitis. For 3 items in this section, those who answered never/rarely were considered to have a positive (favorable) response.

Time frame: 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.

Population: The baseline QOL was not completed by 4 subjects enrolled in the study. 12 week evaluation: 2 subjects failed to complete the QOL. 26 week evaluation: 2 subjects withdrew from the study prior to the 26 week visit. 52 week evaluation: 1 additional subject was lost to follow-up at this visit.

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.

Time frame: Comparison of scores at Baseline and 12 weeks post procedure

Population: The analyzed population excludes one subject who did not complete the rTNSS questionnaire at the 12 week follow-up visit due to oversight.