Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects With Chronic Rhinitis (PARAGON)

Inclusion criteria

Subjects MUST:

• Be ≥18 years of age.
• Have been experiencing rhinitis symptoms for a minimum of 6 months.
• Have moderate to severe symptoms of runny nose (individual rTNSS symptom rating of 2 or 3), mild to severe symptoms of nasal congestion (individual rTNSS symptom rating of 1,2, or 3), and a minimum total score of 5 (out of 12) at baseline.
• Have an allergy test (by skin prick or intradermal testing, or by a validated in vitroImmunoglobin E [IgE test]) on file within 5 years of the baseline visit or is willing to have one performed during the study prior to 6-month visit.
• Be an appropriate candidate for bilateral NEUROMARK® device treatment performed under local anesthesia.
• Test negative for active COVID-19 at the start of the study screening and continue to be free of COVID-19 symptoms until the time of enrollment/treatment.
• Be willing and able to comply with all study elements, as indicated by written informed consent.

Exclusion criteria

Subjects MUST NOT:

• Have clinically significant anatomic obstruction that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor.
• Have had previous sinus or nasal surgery within 6 months of study enrollment.
• Have previously undergone RF, cryotherapy, or other surgical interventions for rhinitis.
• Have an active nasal or sinus infection.
• Have nasal mucosal erosion/ulceration.
• Have rhinitis symptoms that are due to seasonal allergies only.
• Have plans to (or otherwise anticipates the need to) undergo an ENT procedure concurrently or within 6 months after the study procedure.
• Have started a new sinonasal medication regimen within 4 weeks prior to treatment that, according to the manufacturer's labelling, has not yet stabilized.
• Be on prescribed anticoagulants (eg, warfarin, Plavix) or ≥ 325 mg aspirin that cannot be held for an appropriate time before the procedure.
• Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
• Have numbness of the soft palate, excessive dry eye, excessive dry nose, or other indication of neuro/nerve compromise in the sinonasal cavity.
• Have an active rhinitis medicamentosa or a history of rhinitis medicamentosa within the past 6 months.
• Have been diagnosed with atrophic rhinitis.
• Have had previous head and/or neck irradiation.
• Have an allergy or intolerance to local anesthetic agents.
• Be pregnant.
• Have a physical, neurological, medical, psychiatric condition or situation that, in the investigator's opinion, puts the subject at risk, could confound the study results, or may interfere significantly with the subject's participation in the study.
• Be participating in another clinical research study.