NEUROMARK System for Chronic Rhinitis

Not currently recruiting at 10 trial locations

Overseen By Annalise Sorensen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neurent Medical

Must not be taking: Anticoagulants, High-dose aspirin

Disqualifiers: Nasal obstruction, Recent sinus surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the NEUROMARK System, a new treatment for chronic rhinitis, which causes a persistent runny nose and nasal congestion. The study evaluates the safety and effectiveness of this treatment. Participants should have experienced noticeable rhinitis symptoms for at least six months and suffer from moderate to severe runny nose and nasal congestion that affect daily life. Those who meet these criteria might find this trial a valuable opportunity to explore new treatment options. As an unphased trial, it offers a unique chance to contribute to groundbreaking research and potentially benefit from an innovative treatment.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot start a new sinonasal medication regimen within 4 weeks before treatment. Also, if you are on prescribed anticoagulants or high-dose aspirin, you must be able to stop them for a suitable time before the procedure.

What prior data suggests that the NEUROMARK System is safe for chronic rhinitis?

Research has shown that the NEUROMARK System safely treats chronic rhinitis. One study found that participants experienced significant improvement after three months. Possible side effects include bleeding, pain, discomfort after the procedure, and allergic reactions to anesthesia. These side effects are common with many medical treatments. Overall, the NEUROMARK System appears to be a safe and effective method for managing chronic rhinitis symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The NEUROMARK System is unique because it offers a novel approach to treating chronic rhinitis by targeting the nerves responsible for the condition. Unlike standard treatments like antihistamines or nasal steroids, which primarily address symptoms, the NEUROMARK System focuses on modulating nerve activity within the nasal passages. Researchers are excited about this treatment because it has the potential to provide longer-lasting relief by addressing the root cause of the symptoms rather than just masking them.

What evidence suggests that the NEUROMARK System is effective for chronic rhinitis?

Research has shown that the NEUROMARK System, which participants in this trial will receive, effectively treats chronic rhinitis, a condition causing a runny nose and congestion. Previous studies found significant improvements, with runny nose and congestion symptoms improving by 53% and 55%, respectively. After two years, 76% of participants reported a 55% improvement in overall nasal symptoms. The treatment uses radio waves to target and treat specific nasal nerves, providing lasting relief. Designed to be minimally invasive, it doesn't require major surgery. Overall, the NEUROMARK System offers a promising option for those dealing with chronic rhinitis. ^{1 2 3 6 7}

Who Is on the Research Team?

Annalise Sorensen

Principal Investigator

Neurent Medical

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic rhinitis, experiencing symptoms like a runny nose and nasal congestion for at least 6 months. They must have had an allergy test within the last 5 years or be willing to take one. Participants should not have active COVID-19, recent nasal surgery, plans for ENT procedures soon, or be on certain blood thinners. Pregnant individuals and those with specific medical conditions that could interfere with the study are excluded.

Inclusion Criteria

Be willing and able to comply with all study elements, as indicated by written informed consent

I am a suitable candidate for a NEUROMARK® device treatment under local anesthesia.

I have had symptoms of rhinitis for at least 6 months.

Exclusion Criteria

I am taking blood thinners that cannot be stopped before a procedure.

I currently have a nasal or sinus infection.

My runny nose and sneezing are caused by seasonal allergies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects will undergo treatment with the NEUROMARK System

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• NEUROMARK System

Trial Overview

The PARAGON study is testing the NEUROMARK System's safety and effectiveness in treating chronic rhinitis symptoms. This single-arm trial involves multiple centers where participants will undergo treatment under local anesthesia to see if their condition improves.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Subjects will undergo treatment with the NEUROMARK System

NEUROMARK System is already approved in United States for the following indications:

Approved in United States as NEUROMARK System for:

• Chronic rhinitis

Who Is Running the Clinical Trial?

Neurent Medical

Lead Sponsor

Trials

5

Recruited

540+

Published Research Related to This Trial

The NEUROMARK® system, a radiofrequency ablation device, was found to be safe and effective for treating chronic rhinitis, with no serious adverse events reported during the study involving 36 participants.

At 3 months post-treatment, participants showed significant improvements in nasal symptoms, with a 53% reduction in rhinorrhea and a 55% reduction in nasal congestion, along with a high responder rate of 78% for overall symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a novel multipoint radiofrequency ablation device to treat chronic rhinitis. Reh, DD., Lay, K., Davis, G., et al.[2023]

In a study of Artemisia pollen allergic patients undergoing at least 1 year of allergen immunotherapy (AIT), only those who responded to treatment showed elevated levels of specific IgE and IgG4, indicating a potential link between these antibodies and successful AIT outcomes.

The study identified leukotriene A4 hydrolase (LTA4H) as a promising biomarker for predicting AIT effectiveness, with significant increases in LTA4H levels observed in responders after treatment, suggesting it could help select patients who are likely to benefit from AIT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leukotriene A4 Hydrolase Is a Candidate Predictive Biomarker for Successful Allergen Immunotherapy. Ma, TT., Cao, MD., Yu, RL., et al.[2021]

The Rhinitis Control Assessment Test (RCAT) is a reliable and valid tool for evaluating rhinitis symptom control, with internal consistency and test-retest reliability scores of 0.77 and 0.78, respectively, based on a study of 402 patients aged 12 and older.

A cut-point score of 21 or less on the RCAT can effectively identify patients with rhinitis symptom control issues, and the minimal important difference (MID) was estimated to be 3 points, making it a practical tool for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability, validity, and responsiveness of the Rhinitis Control Assessment Test in patients with rhinitis. Meltzer, EO., Schatz, M., Nathan, R., et al.[2022]

The Brazilian Portuguese version of the Rhinitis Control Assessment Test (RCAT) was validated with a study involving 141 adolescents with allergic rhinitis, showing good internal consistency (0.73) and significant correlations with nasal symptoms and airflow measurements.

Using a cutoff score of 22 on the RCAT effectively distinguished between controlled and uncontrolled allergic rhinitis, indicating its utility as a reliable tool for assessing rhinitis control in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translation into Portuguese and validation of the Rhinitis Control Assessment Test (RCAT) questionnaire. Fernandes, PH., Matsumoto, F., Solé, D., et al.[2022]

The Rhinitis Control Assessment Test (RCAT) was developed through a qualitative process involving 39 patients in focus groups and 23 in cognitive interviews, aiming to create a tool for better monitoring of allergic rhinitis symptoms.

The draft instrument includes 26 items that assess various aspects of rhinitis control, such as symptom frequency, impact on activities, and medication use, with a five-point response scale and a one-week recall period, which were chosen based on patient feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Development of the Rhinitis Control Assessment Test (RCAT), an Instrument for Evaluating Rhinitis Symptom Control. Nathan, RA., Dalal, AA., Stanford, RH., et al.[2021]

The Rhinitis Control Assessment Test (RCAT) is a simple, self-administered questionnaire designed to help both physicians and patients assess and understand rhinitis control, making it easier to monitor symptoms over time.

By providing a clear rhinitis score, the RCAT aims to improve the quality of care for patients suffering from allergic and nonallergic rhinitis, addressing the complex nature of managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The rhinitis control assessment test: implications for the present and future. Nathan, RA.[2015]

In a study involving 30 patients (15 with allergic rhinitis and 15 with idiopathic rhinitis), nerve growth factor (NGF) levels were significantly higher in patients with allergic rhinitis, suggesting a link between NGF and the severity of symptoms.

Increased perivascular innervation was associated with more intense clinical symptoms, indicating that NGF produced by inflammatory cells may stimulate nerve growth, contributing to the heightened symptoms observed in allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perivascular Innervation in the Nasal Mucosa and Clinical Findings in Patients with Allergic Rhinitis and Idiopathic Rhinitis. Carvalho, T., Mello, JF., Caldini, ETEG., et al.[2023]

Citations

1.

neuromark.com

neuromark.com/resource/new-data-show-neuromark-r-chronic-rhinitis-treatment-offers-significant-symptom-improvements

New Data show NEUROMARK® Chronic Rhinitis ...

The mean VAS NSS scores for rhinorrhea and nasal congestion significantly improved from baseline (both p<0.0001), achieving a mean percent change of 53% and 55% ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10116986/

Clinical evaluation of a novel multipoint radiofrequency ...

The NEUROMARK System is a novel radiofrequency ablation device that provides safe and effective treatment to the posterior nasal nerves for patients with ...

3.

neuromark.com

neuromark.com/resource/neuromark-r-treatment-for-chronic-rhinitis-demonstrates-durable-2-year-clinical-benefits

NEUROMARK® Treatment for Chronic Rhinitis ...

The mean reflective Total Nasal Symptom Score (rTNSS) improved by 55% from baseline at 2 years (p<.0001). 76% of participants achieved the ...

4.

neuromark.com

neuromark.com/

Neurent Medical | NEUROMARK for Chronic Rhinitis

Discover NEUROMARK, a minimally invasive solution for Chronic Rhinitis that targets the posterior nasal nerve to provide lasting symptom relief.

5.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/01455613241285134

Clinical Outcomes After Innovative Multipoint Impedance ...

Subgroup analysis by rhinitis type (allergic vs nonallergic) showed significant within-group improvements from baseline to 6 months for the ...

6.

neuromark.com

neuromark.com/important-safety-information

Important Safety Information

Possible side effects include but are not limited to post-operative bleeding, pain or discomfort, allergic reaction to anesthesia or other medication ...

7.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT04769596

NCT04769596 | Safety and Efficacy Study of the Neurent ...

The NEUROMARK™ System is designed to deliver energy to the nasal cavity intended to interrupt nasal nerves aimed to reduce symptoms related to Chronic Rhinitis.