NEUROMARK Randomized Controlled Trial

Subjects in this arm will undergo treatment with the NEUROMARK device.

Device: NEUROMARK System

Subjects in this arm will undergo the procedure with a Sham device. Sham control participants will be offered the option to receive active treatment after the 90-day follow-up provided they still meet all eligibility criteria.

Device: Sham NEUROMARK System

The NEUROMARK System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis.

Sham ablation procedure using the NEUROMARK System

Plazo: 90-days post procedure follow-up

Percentage of responders (participants with a 30% or greater reduction in total rTNSS relative to baseline). The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. Max score: 12 Min score: 0. Lower values indicate a better outcome. 4 subscales (0-3 score) add together to create total score (out of 12). 30% or greater reduction in score from baseline.

Plazo: 90-Days post procedure follow up

Mean change from baseline in the rTNSS score. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. Max score: 12 Min score: 0. Lower values indicate a better outcome. 4 subscales (0-3 score) add together to create total score (out of 12).

Plazo: 90 days post procedure follow up

Mean change from baseline in the NOSE score. The NOSE (Nasal Obstruction Symptom Evaluation) scale is a 5-question patient-reported survey used to measure the severity of nasal obstruction and its impact on quality of life. Max Score: 100; Min Score: 0. Lower values indicate a better outcome. Each question is added for a raw score (ranging from 0 to 20) and then the raw score is multiplied by 5 yielding a final total (ranging from 0 to 100).

Plazo: 90 days post procedure follow up

Mean change from baseline in the Mini-RQLQ score. The Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) is an abbreviated, 14-item self-administered health status questionnaire designed to measure functional impairments in adults with seasonal or perennial rhinoconjunctivitis. Max Score: 6 Min Score: 0. Lower values indicate a better outcome. Each question is scored 0-6 and the 14 question responses are averaged to create a total score.

Plazo: 90 days post procedure follow up

Number of participants with Incidences of device- and/or procedure-related serious adverse events (SAEs)

Plazo: 90 Days post procedure follow up

Mean change in rTNSS congestion subscore. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Congestion. Max score: 3 Min score: 0. Lower values indicate a better outcome.

Plazo: 90 Days post procedure follow up

Mean change in rTNSS rhinorrhea subscore. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Rhinorrhea. Max score: 3 Min score: 0. Lower values indicate a better outcome.

Plazo: 90 Days post procedure follow up

Mean change in rTNSS sneezing subscore. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Sneezing. Max score: 3 Min score: 0. Lower values indicate a better outcome.

Plazo: 90 Days post procedure follow up

Mean change in rTNSS itching subscore. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Nasal Itching. Max score: 3 Min score: 0. Lower values indicate a better outcome.

Plazo: 90 days post procedure follow up

Mean change from baseline in postnasal drip score. Postnasal drip is a single question evaluating severity of symptom in the past 12 hours on a scale from 0 to 3. Max score: 3 Min Score: 0. Lower values indicate a better outcome.

Plazo: 90 days post procedure follow up

Mean change from baseline in cough score. Cough assessment is a single question rating severity of symptom in the past 12 hours on a scale from 0 to 3. Max score: 3 Min Score: 0. Lower scores indicate a better outcome.

Plazo: 90 days post procedure follow up

The percent of NOSE responders (at least one NOSE class improvement or reduction of greater than or equal to 20% compared to baseline). The NOSE (Nasal Obstruction Symptom Evaluation) scale is a 5-question patient-reported survey used to measure the severity of nasal obstruction and its impact on quality of life. Max Score: 100; Min Score: 0. Lower values indicate a better outcome. Each question is added for a raw score (ranging from 0 to 20) and then the raw score is multiplied by 5 yielding a final total (ranging from 0 to 100). The percent of NOSE responders with at least one NOSE class improvement or reduction of greater than or equal to 20%.

Plazo: 90 Day Post Procedure Follow Up

Mean change from baseline in NOSE nasal congestion subscore. The NOSE (Nasal Obstruction Symptom Evaluation) scale is a 5-question patient-reported survey used to measure the severity of nasal obstruction and its impact on quality of life. The NOSE Nasal Congestion subscore is a single question rated 0 to 4. Max score: 4 Min score: 0. Lower values indicate a better outcome.

Plazo: 90 Day Post Procedure Follow Up

Mean change from baseline in NOSE Nasal blockage/obstruction subscore. The NOSE (Nasal Obstruction Symptom Evaluation) scale is a 5-question patient-reported survey used to measure the severity of nasal obstruction and its impact on quality of life. The NOSE Nasal Blockage/obstruction subscore is a single question rated 0 to 4. Max score: 4 Min score: 0. Lower values indicate a better outcome.

Plazo: 90 Day Post Procedure Follow Up

Mean change from baseline in NOSE Trouble breathing through nose subscore. The NOSE (Nasal Obstruction Symptom Evaluation) scale is a 5-question patient-reported survey used to measure the severity of nasal obstruction and its impact on quality of life. The NOSE Trouble breathing through nose subscore is a single question rated 0 to 4. Max score: 4 Min score: 0. Lower values indicate a better outcome.

Plazo: 90 Days Post Procedure Follow Up

Mean change from baseline in NOSE Trouble sleeping subscore. The NOSE (Nasal Obstruction Symptom Evaluation) scale is a 5-question patient-reported survey used to measure the severity of nasal obstruction and its impact on quality of life. The NOSE Trouble sleeping subscore is a single question rated 0 to 4. Max score: 4 Min score: 0. Lower values indicate a better outcome.

Plazo: 90 Day Post Procedure Follow Up

Mean change from baseline in NOSE Difficulty getting air through nose during exercise subscore. The NOSE (Nasal Obstruction Symptom Evaluation) scale is a 5-question patient-reported survey used to measure the severity of nasal obstruction and its impact on quality of life. The NOSE Difficulty getting air through nose during exercise subscore is a single question rated 0 to 4. Max score: 4 Min score: 0. Lower values indicate a better outcome.

Plazo: 90 days post procedure follow up

The percent of participants achieving the MCID in Mini-RQLQ score (greater than or equal to .4 point improvement compared to baseline). The Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) is an abbreviated, 14-item self-administered health status questionnaire designed to measure functional impairments in adults with seasonal or perennial rhinoconjunctivitis. Max Score: 6 Min Score: 0. Lower values indicate a better outcome. Each question is scored 0-6 and the 14 question responses are averaged to create a total score.

Plazo: 90 Day Post Procedure Follow Up

Mean change from baseline in Mini-RQLQ activities domain score. The Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) is an abbreviated, 14-item self-administered health status questionnaire designed to measure functional impairments in adults with seasonal or perennial rhinoconjunctivitis. The Activities (including sleep) domain score is calculated by averaging responses from 3 questions regarding regular activities rated from 0-6. Max Score: 6 Min Score: 0. Lower values indicate a better outcome.

Plazo: 90 day post procedure follow up

Mean change from baseline in Mini-RQLQ practical problems domain score. The Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) is an abbreviated, 14-item self-administered health status questionnaire designed to measure functional impairments in adults with seasonal or perennial rhinoconjunctivitis. The Practical Problems domain score is calculated by averaging responses from 2 questions regarding practical problems rated from 0-6. Max Score: 6 Min Score: 0. Lower values indicate a better outcome.

Plazo: 90 days post procedure follow up

Mean change from baseline in Mini-RQLQ nose symptoms domain score. The Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) is an abbreviated, 14-item self-administered health status questionnaire designed to measure functional impairments in adults with seasonal or perennial rhinoconjunctivitis. The Nose symptoms domain score is calculated by averaging responses from 3 questions regarding nose symptoms rated from 0-6. Max Score: 6 Min Score: 0. Lower values indicate a better outcome.

Plazo: 90 day post procedure follow up

Mean change from baseline in Mini-RQLQ eye symptoms domain score. The Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) is an abbreviated, 14-item self-administered health status questionnaire designed to measure functional impairments in adults with seasonal or perennial rhinoconjunctivitis. The Eye Symptoms domain score is calculated by averaging responses from 3 questions regarding eye symptoms rated from 0-6. Max Score: 6 Min Score: 0. Lower values indicate a better outcome.

Plazo: 90 days post procedure follow up

Mean change from baseline in Mini-RQLQ other symptoms domain score. The Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) is an abbreviated, 14-item self-administered health status questionnaire designed to measure functional impairments in adults with seasonal or perennial rhinoconjunctivitis. The Other Symptoms domain score is calculated by averaging responses from 3 questions rated from 0-6. Max Score: 6 Min Score: 0. Lower values indicate a better outcome.

Plazo: 90 days post procedure follow up

Mean change from baseline in PHQ-9 score. The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report tool used to evaluate the presence and severity of depressive symptoms over the past two weeks. Max Score: 81. Min Score: 0. Lower values indicate a better outcome. Responses to each question are added to create a total score.

Randomized Controlled Trial Comparing NEUROMARK System to Sham Control in Patients With Chronic Rhinitis