NEUROMARK System for Chronic Rhinitis

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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is studying the NEUROMARK System, a device for treating people with chronic rhinitis. It aims to see how well the device works in real-world settings by calming overactive nasal passages to reduce symptoms.

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 data supports the idea that NEUROMARK System for Chronic Rhinitis is an effective treatment?

The available research shows that the NEUROMARK System is effective in treating chronic rhinitis. It highlights the safety and success of this treatment in managing the condition. However, there is no direct comparison to other treatments in the provided information. ^{1 2 3 4 5}

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 in managing symptoms. Additionally, the Rhinitis Control Assessment Test (RCAT) is a tool used to monitor rhinitis symptom control, which can help assess the treatment's impact on patients. ^{1 2 3 4 5}

What safety data exists for the NEUROMARK System for chronic rhinitis?

The safety and efficacy of the NEUROMARK System for treating chronic rhinitis are evaluated in the study titled 'Clinical evaluation of a novel multipoint radiofrequency ablation device to treat chronic rhinitis.' This study specifically addresses the safety of the NEUROMARK System. ^{1 2 4 5 6}

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 4 5 6}

Is the NEUROMARK System a promising treatment for chronic rhinitis?

Yes, the NEUROMARK System is a promising treatment for chronic rhinitis because it has been shown to be safe and effective in treating this condition. ^{1 2 4 5 7}

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, which is a technique that applies heat to specific areas to reduce symptoms, unlike traditional treatments that often rely on medications or allergen immunotherapy. ^{1 2 4 5 7}

Research Team

Annalise Sorensen

Principal Investigator

Neurent Medical

Eligibility Criteria

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.

I am 18 years old or older.

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

Exclusion Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

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 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 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 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) 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

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

3. Brazil pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

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]