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

NCT05591989 | Completed FDA Device

• 1 other identifier: CIP-0007
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Chronic Rhinitis

Keywords

Rhinitis

Outcome Measures

Primary Outcomes (2)

• Safety Outcome

  Safety, as assessed by the incidence of device- and/or procedure related serious adverse events (SAEs)

  24 months

• Efficacy Outcome

  Efficacy, as assessed by the mean change from baseline in nasal symptoms using the 4-symptom rTNSS (reflective Total Nasal Symptom Score) at 6-month follow-up (FU)

  6 months

Secondary Outcomes (6)

• The mean change from baseline in rTNSS total score (except 6-month FU)

  24 months

• The mean change from baseline in rTNSS subscores

  24 months

• The mean change from baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ) score

  24 months

• The mean change from baseline in Clinical Global Impression -Improvement (CGI-I) score

  24 months

• Percent of subject satisfaction at follow-up

  24 months

Study Arms (1)

Treatment

EXPERIMENTAL

Subjects will undergo treatment with the NEUROMARK System

Device: NEUROMARK System

Interventions

NEUROMARK System DEVICE

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Neurent Medical: lead

Study Sites (10)

Alabama Nasal and Sinus Center (Alabama Allergy)

Birmingham, Alabama, 35242, United States

Location

Sacramento ENT

California City, California, 95661, United States

Location

United Medical Doctors

Temecula, California, 92592, United States

Location

Colorado ENT

Colorado Springs, Colorado, 80923, United States

Location

New Orleans Sinus Center

Marrero, Louisiana, 70072, United States

Location

Centers for Advanced ENT Care (CAdENT)

Baltimore, Maryland, 21204, United States

Location

Rontal Clinics

Royal Oak, Michigan, 48073, United States

Location

Specialty Physician Associates

Bethlehem, Pennsylvania, 18017, United States

Location

Richmond ENT

Richmond, Virginia, 23235, United States

Location

Ear Nose Throat & Allergy Associates

Seattle, Washington, 98374-1145, United States

Location

Related Publications (2)

• 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.

  PMID: 41065547 DERIVED

• 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.

  PMID: 39315465 DERIVED

MeSH Terms

Conditions

Rhinitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Annalise Sorensen

  Neurent Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, single-arm, multicenter clinical study

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 24, 2022
• Study Start: September 26, 2022
• Primary Completion: August 5, 2025
• Study Completion: August 5, 2025
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)