NEUROMARK System for Chronic Rhinitis

Not currently recruiting at 6 trial locations

Overseen By Kevin Choi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neurent Medical

Disqualifiers: Chronic epistaxis, 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: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather real-world data on the NEUROMARK System, a treatment for chronic rhinitis, which causes persistent runny nose and nasal congestion. The focus is to evaluate the system's effectiveness for individuals experiencing these uncomfortable symptoms daily. The trial seeks participants with moderate to severe symptoms of a runny nose and nasal congestion who are set to receive the NEUROMARK treatment. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance treatment options for chronic rhinitis.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that the NEUROMARK System is safe for individuals with long-term nasal issues like chronic rhinitis. One study found that after three months of treatment, participants experienced significant relief from symptoms such as a runny or stuffy nose. Another study highlighted that the NEUROMARK System safely targets the overactive nasal nerves, often responsible for chronic rhinitis. This indicates that the treatment is generally well-tolerated. The research does not report any severe side effects, which is reassuring for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for chronic rhinitis, which usually involve medications like antihistamines or nasal corticosteroids, the NEUROMARK System offers a novel approach by using a device-based intervention. This system targets the nerves responsible for the symptoms of chronic rhinitis, aiming to provide relief without the need for ongoing medication. Researchers are excited about the NEUROMARK System because it could offer long-lasting symptom control with a single procedure, potentially improving the quality of life for patients who have not found relief with traditional therapies.

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. In studies, patients experienced significant improvements in symptoms such as runny and stuffy noses. Specifically, scores measuring these symptoms improved by 53% and 55%. Over two years, the overall nasal symptom score improved by 55%, with 76% of participants experiencing long-lasting relief. This treatment uses a radiofrequency device to safely and effectively target and treat the nerves in the back of the nose. ^{1 2 3 4 6}

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 who are about to receive the NEUROMARK System treatment. Participants should have moderate to severe runny nose and mild to severe nasal congestion, scoring at least 5 out of 12 on a symptom scale. They must consent and follow study procedures.

Inclusion Criteria

I have a runny nose and nasal congestion with a symptom score of at least 5 out of 12.

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

I am scheduled for treatment with the NEUROMARK System as recommended.

Exclusion Criteria

I have had severe nosebleeds needing medical help in the last 3 months.

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

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

What Are the Treatments Tested in This Trial?

Interventions

• NEUROMARK System

Trial Overview The NEUROMARK Registry Study is evaluating the real-world use of the NEUROMARK System in treating chronic rhinitis. It's an observational study collecting data from multiple centers on how well this system works after it has been sold.

How Is the Trial Designed?

Group I: NEUROMARK Treatment Experimental Treatment 1 Intervention

Interventional registry to collect real world data - Subjects will undergo treatment with the NEUROMARK System.

Who Is Running the Clinical Trial?

Neurent Medical

Lead Sponsor

Trials

5

Recruited

540+

Published Research Related to This Trial

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]

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 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]

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 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 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) 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]

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. anthem.com anthem.com/medpolicies/abc/active/mp_pw_e000642.html

SURG.00157 Minimally Invasive Treatment of the Posterior ... A prospective single-arm study reported on the 6-month outcomes of individuals who underwent radiofrequency neurolysis of the PNN to treat ...

6. 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.