Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis (CLARITY)

Exclusion Criteria

• •Subject has clinically significant anatomic obstruction that limits access to the posterior nose as determined by the Study Investigator such as severe septal deviation, prior surgical considerations, cleft palate, nasal polyps, or sino-nasal tumor.
• •Subject has an active nasal or sinus infection at the time of treatment.
• •Subject has a diagnosis of Atrophic Rhinitis.
• •Subject has a Lund-Mackay score \>3 during the screening phase, an active history of chronic sinusitis (within the last year).
• •Subject has a septal perforation or nasal mucosal erosion/ulceration.
• •Subject experiences numbness of the soft palate, excessive dry eye, excessive dry nose, or other indication of neuro/nerve compromise in the sino-nasal anatomy.
• •Subject has had prior sinus or nasal surgery that may prevent access or proper placement of the NEUROMARK™ System.
• •Subject has had prior head or neck irradiation (head/neck cancer therapy).
• •Subject has an allergy or intolerance to anaesthetic agent or other study-required materials.
• •Subject is taking anticoagulant medication or 325 mg aspirin that cannot be discontinued before the procedure and for the length of the study.
• •Subject has a history of nasal manifestation of rheumatic disease.
• •Subject has started a new sino-nasal medication regimen within 4 weeks prior to treatment (i.e. antihistamines, cromolyn, leukotriene receptor antagonists, inhaled or systemic steroids, anticholinergics, expectorants, decongestants) that, per the manufacturer's labelling, has not yet stabilized.
• •Subject has uncontrolled Hypothyroidism.
• •Subject has uncontrolled Hypertension (stage 2 or higher).
• •Subject is an active smoker or has been a smoker within the last 6 months (patient reported).
• •Any physical condition that in the Investigator's opinion would prevent adequate study participation or pose increased risk to the study Subject.
• •Subject is pregnant, nursing or plans to become pregnant during the study, or is a WOCBP, but is not willing to use an effective method of birth control.
• •Patient is enrolled in an investigational drug or device study or has participated in such a study within the last 30 days prior to screening that in the opinion of the Investigator would interfere with the study results.
• •Patient presents with any condition or situation which, 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.
• •Subject presents with acute sinusitis at time of treatment or other sino-nasal related illness other than rhinitis.
• •Subject has history of chronic epistaxis or nosebleed episodes within the last 12 months.
• •Subject has rhinitis symptoms due to seasonal allergies only.
• •Subject has received previous procedure or surgery for chronic rhinitis and/or to disrupt the posterior nasal nerve.