NEUROMARK System for Chronic Rhinitis

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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new device called the NEUROMARK System to help people with chronic rhinitis, a condition where the nose stays inflamed for a long time. The device works by calming the nerves in the nose to reduce inflammation and improve symptoms.

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 data supports the effectiveness of the NEUROMARK System treatment for chronic rhinitis?

The NEUROMARK System has been evaluated for safety and effectiveness in treating chronic rhinitis, showing promise as a novel approach. Additionally, the study on perivascular innervation suggests that targeting nerve growth factors could help manage rhinitis symptoms, which aligns with the NEUROMARK System's focus on neurolysis (nerve treatment). ^{1 2 3 4 5}

Is the NEUROMARK System safe for treating chronic rhinitis?

The NEUROMARK System has been evaluated for safety in treating chronic rhinitis, indicating it is generally safe for use in humans. ^{1 2 3 4 6}

How is the NEUROMARK System treatment for chronic rhinitis different from other treatments?

The NEUROMARK System is unique because it uses a novel multipoint radiofrequency ablation device to treat chronic rhinitis, which is different from traditional treatments that often involve medications or allergen immunotherapy. This approach targets the nerves in the nasal passages to reduce symptoms, offering a new option for patients who may not respond well to other therapies. ^{1 2 3 4 7}

Research Team

Annalise Sorensen

Principal Investigator

Neurent Medical

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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 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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Qualitative Development of the Rhinitis Control Assessment Test (RCAT), an Instrument for Evaluating Rhinitis Symptom Control. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Reliability, validity, and responsiveness of the Rhinitis Control Assessment Test in patients with rhinitis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a novel multipoint radiofrequency ablation device to treat chronic rhinitis. [2023]

4. Brazil pubmed.ncbi.nlm.nih.gov

Translation into Portuguese and validation of the Rhinitis Control Assessment Test (RCAT) questionnaire. [2022]

5. Brazil pubmed.ncbi.nlm.nih.gov

Perivascular Innervation in the Nasal Mucosa and Clinical Findings in Patients with Allergic Rhinitis and Idiopathic Rhinitis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

Leukotriene A4 Hydrolase Is a Candidate Predictive Biomarker for Successful Allergen Immunotherapy. [2021]