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

Completed · Not applicable

Conditions studied: Chronic Rhinitis

In brief

The PARAGON Study is a prospective, single-arm, multicenter safety and efficacy study of the Neurent Medical NEUROMARK System in subjects with chronic rhinitis.

Key facts

Study ID

NCT05591989

Run by

Neurent Medical

People needed

80

Starts

2022-09-26

Expected to finish

2025-08-05

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Alabama Nasal and Sinus Center (Alabama Allergy) — Birmingham, Alabama, United States
• Sacramento ENT — California City, California, United States
• United Medical Doctors — Temecula, California, United States
• Colorado ENT — Colorado Springs, Colorado, United States
• New Orleans Sinus Center — Marrero, Louisiana, United States
• Centers for Advanced ENT Care (CAdENT) — Baltimore, Maryland, United States
• Rontal Clinics — Royal Oak, Michigan, United States
• Specialty Physician Associates — Bethlehem, Pennsylvania, United States
• Richmond ENT — Richmond, Virginia, United States
• Ear Nose Throat & Allergy Associates — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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