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

Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects With Chronic Rhinitis (PARAGON) - A Prospective, Single-arm, Multicenter Clinical Study.

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

Study Overview

• Status: Completed
• Conditions: Chronic Rhinitis
• Intervention / Treatment: Device: NEUROMARK System

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35242
      • Alabama Nasal and Sinus Center (Alabama Allergy)
  • California
    • California City, California, United States, 95661
      • Sacramento ENT
    • Temecula, California, United States, 92592
      • United Medical Doctors
  • Colorado
    • Colorado Springs, Colorado, United States, 80923
      • Colorado ENT
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • New Orleans Sinus Center
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Centers for Advanced ENT Care (CAdENT)
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Rontal Clinics
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Specialty Physician Associates
  • Virginia
    • Richmond, Virginia, United States, 23235
      • Richmond ENT
  • Washington
    • Seattle, Washington, United States, 98374-1145
      • Ear Nose Throat & Allergy Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Subjects MUST:

1. Be ≥18 years of age.
2. Have been experiencing rhinitis symptoms for a minimum of 6 months.
3. 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.
4. 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.
5. Be an appropriate candidate for bilateral NEUROMARK® device treatment performed under local anesthesia.
6. 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.
7. Be willing and able to comply with all study elements, as indicated by written informed consent.

Exclusion Criteria:

Subjects MUST NOT:

1. 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.
2. Have had previous sinus or nasal surgery within 6 months of study enrollment.
3. Have previously undergone RF, cryotherapy, or other surgical interventions for rhinitis.
4. Have an active nasal or sinus infection.
5. Have nasal mucosal erosion/ulceration.
6. Have rhinitis symptoms that are due to seasonal allergies only.
7. Have plans to (or otherwise anticipates the need to) undergo an ENT procedure concurrently or within 6 months after the study procedure.
8. Have started a new sinonasal medication regimen within 4 weeks prior to treatment that, according to the manufacturer's labelling, has not yet stabilized.
9. Be on prescribed anticoagulants (eg, warfarin, Plavix) or ≥ 325 mg aspirin that cannot be held for an appropriate time before the procedure.
10. Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
11. Have numbness of the soft palate, excessive dry eye, excessive dry nose, or other indication of neuro/nerve compromise in the sinonasal cavity.
12. Have an active rhinitis medicamentosa or a history of rhinitis medicamentosa within the past 6 months.
13. Have been diagnosed with atrophic rhinitis.
14. Have had previous head and/or neck irradiation.
15. Have an allergy or intolerance to local anesthetic agents.
16. Be pregnant.
17. 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.
18. Be participating in another clinical research study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Subjects will undergo treatment with the NEUROMARK System	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Total Reflective Total Nasal Symptom Score (rTNSS) at 6 Months [Efficacy]	The reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome assessing nasal congestion, rhinorrhea, sneezing, and nasal itching. Each symptom is scored from 0 (none) to 3 (severe), with a total score range of 0 to 12. A decrease in score indicates improvement in symptoms.	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants achieving ≥30% reduction from baseline in total rTNSS	Responder rate defined as the proportion of participants achieving a ≥30% reduction from baseline in total rTNSS score.	6 months
Percentage of participants achieving minimal clinically important difference (MCID) in total rTNSS	MCID is defined as a reduction of ≥1 point from baseline in total rTNSS score.	6 months
Change from baseline in total Nasal Obstruction Symptom Evaluation (NOSE) score	The NOSE score is a validated patient-reported outcome assessing nasal obstruction. Scores range from 0 to 100, with higher scores indicating worse symptoms. A decrease in total score indicates improvement.	Baseline to 6 months
Percentage of participants achieving response in total NOSE score	Responder rate defined as ≥20% improvement from baseline in total NOSE score or improvement of at least one NOSE severity class.	6 months
Change from baseline in overall mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ) score	The mini-RQLQ is a validated patient-reported outcome assessing quality of life across multiple domains including activities, practical problems, nasal symptoms, eye symptoms, and other symptoms. Scores range from 0 to 6, with higher scores indicating worse quality of life. A decrease in overall score indicates improvement.	Baseline to 6 months
Percentage of participants achieving minimal clinically important difference (MCID) in overall mini-RQLQ	MCID is defined as a reduction of ≥0.4 points from baseline in the overall mini-RQLQ score.	6 months
Change from baseline in overall Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) score	The ETDQ-7 is a patient-reported outcome assessing symptoms of Eustachian tube dysfunction. Scores range from 1 to 7, with higher scores indicating worse symptoms. A decrease in overall score indicates improvement.	Baseline to 6 months
Change from baseline in postnasal drip symptom score	Postnasal drip is assessed on a scale from 0 (none) to 3 (severe). A decrease from baseline indicates improvement in symptoms.	Baseline to 6 months
Change from baseline in cough symptom score	Cough is assessed on a scale from 0 (none) to 3 (severe). A decrease from baseline indicates improvement in symptoms.	Baseline to 6 months
Incidence of Device- and/or Procedure-Related Serious Adverse Events (SAEs)	The number of participants experiencing serious adverse events that are assessed as related to the device or procedure.	6 months

Collaborators and Investigators

• Sponsor: Neurent Medical
• Investigators: Study Director: Annalise Sorensen, Neurent Medical

Publications and helpful links

General Publications

• Yen DM, Davis GE, Ow RA, O'Malley EM, Del Signore AG. Two-Year Clinical Outcomes After Multipoint Impedance-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve for Treatment of Chronic Rhinitis. Ear Nose Throat J. 2025 Oct 9:1455613251382759. doi: 10.1177/01455613251382759. Online ahead of print.
• Davis GE, Ow RA, Yen DM, O'Malley EM, Del Signore AG. Clinical Outcomes After Innovative Multipoint Impedance-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve for Treatment of Chronic Rhinitis. Ear Nose Throat J. 2024 Sep 24:1455613241285134. doi: 10.1177/01455613241285134. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Actual): August 5, 2025
• Study Completion (Actual): August 5, 2025

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 20, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Rhinitis
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis
• Other Study ID Numbers: CIP-0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No