NEUROMARK System for Chronic Rhinitis
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Neurent Medical
No Placebo Group
Approved in 1 Jurisdiction
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.
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.
12345What 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.
12456Eligibility 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
+1 more
Exclusion Criteria
I have had severe nosebleeds needing medical help in the last 3 months.
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: NEUROMARK TreatmentExperimental Treatment1 Intervention
Interventional registry to collect real world data - Subjects will undergo treatment with the NEUROMARK System.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ogden ClinicOgden, UT
Alabama Nasal & Sinus CenterBirmingham, AL
Florida ENT & AllergyBrandon, FL
Metropolitan ENTAlexandria, VA
More Trial Locations
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Who Is Running the Clinical Trial?
Neurent MedicalLead Sponsor
References
Qualitative Development of the Rhinitis Control Assessment Test (RCAT), an Instrument for Evaluating Rhinitis Symptom Control. [2021]: Effective management of allergic rhinitis requires ongoing monitoring of its control. This article describes the qualitative phase of development of a patient-completed instrument, the Rhinitis Control Assessment Test (RCAT), designed to assist patients and providers in the detection of problems with rhinitis symptom control.
Clinical evaluation of a novel multipoint radiofrequency ablation device to treat chronic rhinitis. [2023]Safety and efficacy of the NEUROMARK® system for treating chronic rhinitis.
Perivascular Innervation in the Nasal Mucosa and Clinical Findings in Patients with Allergic Rhinitis and Idiopathic Rhinitis. [2023]Introduction  The nonspecific hyperreactivity of rhinitis has been attributed to neurotrophins activating sensory nerves and inflammatory cells. The relationship between these markers and the intensity of the symptoms is not well established and few studies have evaluated individuals with idiopathic rhinitis. Objective  The present study aims to evaluate whether perivascular innervation and nerve growth factor (NGF) are related to the intensity of the clinical conditions in allergic rhinitis (AR) and idiopathic rhinitis (IR). Methods  A total of 15 patients with AR and 15 patients with IR with the indication for inferior turbinectomy (associated or not with septoplasty) were selected. The patients received a score according to their signs and symptoms. After the surgery, we quantified eosinophils, mast cells, NGF, and nerve fibers in the nasal turbinate. Results  The score of the signs and symptoms was higher in the AR group. Nerve growth factor was found in the cytoplasm of inflammatory cells in the submucosa in greater quantity in the AR group. The nerve fibers were distributed throughout the tissue, mainly in the subepithelial, glandular, and vascular regions, and there was no difference between the groups. Greater perivascular innervation was associated with a higher signs and symptoms score. Conclusions  We concluded that these findings suggest that the NGF produced by submucosal inflammatory cells stimulates increased perivascular innervation in rhinitis, thus directly reflecting in more intense clinical conditions, especially in AR.
Reliability, validity, and responsiveness of the Rhinitis Control Assessment Test in patients with rhinitis. [2022]The Rhinitis Control Assessment Test (RCAT) is a brief, patient-completed tool to evaluate rhinitis symptom control.
Translation into Portuguese and validation of the Rhinitis Control Assessment Test (RCAT) questionnaire. [2022]The Rhinitis Control Assessment Test (RCAT) is a simple self-administered questionnaire developed to assess control of rhinitis.
The rhinitis control assessment test: implications for the present and future. [2015]To summarize the development of the Rhinitis Control Assessment Test (RCAT), its usefulness in clinical practice, and the benefit it provides for patients who are bothered by allergic and nonallergic rhinitis.
Leukotriene A4 Hydrolase Is a Candidate Predictive Biomarker for Successful Allergen Immunotherapy. [2021]Allergic rhinitis is a common disorder that affects 10% to 40% of the population worldwide. Allergen immunotherapy (AIT) represents the only therapy that has the potential to resolve clinical symptoms of allergic rhinitis. However, up to 30% of patients do not respond to AIT. Biomarkers predicting the clinical efficacy of AIT as early as possible would significantly improve the patient selection and reduce unnecessary societal costs.