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Chronic RhinitisNCT05591989

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

A study testing NEUROMARK System in people with Chronic Rhinitis, run by Neurent Medical at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Rhinitis
What is being tested?
NEUROMARK System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
10 sitesUnited States
Study dates
26 Sep 2022to 5 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Centers for Advanced ENT Care (CAdENT)

    Baltimore, Maryland, 21204

  • Specialty Physician Associates

    Bethlehem, Pennsylvania, 18017

  • Alabama Nasal and Sinus Center (Alabama Allergy)

    Birmingham, Alabama, 35242

  • Sacramento ENT

    California City, California, 95661

  • Colorado ENT

    Colorado Springs, Colorado, 80923

  • New Orleans Sinus Center

    Marrero, Louisiana, 70072

  • Richmond ENT

    Richmond, Virginia, 23235

  • Rontal Clinics

    Royal Oak, Michigan, 48073

  • Ear Nose Throat & Allergy Associates

    Seattle, Washington, 98374-1145

  • United Medical Doctors

    Temecula, California, 92592

Other trials in United States

About this study

Official title: 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.

Being tested
NEUROMARK System
Keywords
Rhinitis
Medical subject headings
Rhinitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NEUROMARK SystemDevice

    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.

Study groups in NCT05591989
Study groupRoleWhat they receive
TreatmentExperimentalSubjects will undergo treatment with the NEUROMARK System
Receives: Device: NEUROMARK System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 6 months

Secondary outcomes (10)

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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.

    Measured: Baseline to 6 months

  4. 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.

    Measured: 6 months

  5. 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.

    Measured: Baseline to 6 months

  6. 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.

    Measured: 6 months

  7. 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.

    Measured: Baseline to 6 months

  8. 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.

    Measured: Baseline to 6 months

  9. 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.

    Measured: Baseline to 6 months

  10. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2022
  2. Study start26 Sep 2022
  3. Primary completion5 Aug 2025
  4. Study completion5 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A prospective, single-arm, multicenter clinical study
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05591989
Sponsor's protocol ID
CIP-0007
Status last verified
May 2026
First submitted
18 Oct 2022
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 41065547

  • 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.

    PubMed 39315465

Questions about this trial

What is this clinical trial studying?

A study testing NEUROMARK System in people with Chronic Rhinitis, run by Neurent Medical at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Total Reflective Total Nasal Symptom Score (rTNSS) at 6 Months [Efficacy] (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05591989, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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