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NEUROMARK System for Chronic Rhinitis

N/A
Recruiting
Research Sponsored by Neurent Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have moderate to severe symptoms of running nose (individual rTNSS symptom rating of 2 or 3), mild to severe symptoms of nasal congestion (individual rTNSS symptom rating of 1, 2, or 3), and a minimum total score of 5 (out of 12) at screening
Be ≥18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36-month follow-up
Awards & highlights

Summary

This trial will collect data on how a medical device works in people with chronic rhinitis.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, patients with a history of frequent or significant nosebleeds requiring medical help, especially within the last three months, cannot participate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a runny nose and nasal congestion with a symptom score of at least 5 out of 12.
Select...
I am 18 years old or older.
Select...
I am scheduled for treatment with the NEUROMARK System as recommended.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Safety - incidence of device- and/or procedure-related serious adverse

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NEUROMARK System
2022
N/A
~40

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Neuromodulation treatments for chronic rhinitis, such as those being studied in the NEUROMARK System trial, work by targeting specific nerves involved in the inflammatory response of the nasal mucosa. By modulating the activity of these nerves, these treatments can reduce inflammation and improve nasal airflow, providing significant symptom relief. This approach is crucial for chronic rhinitis patients as it offers a non-pharmacological option that can alleviate persistent symptoms without the side effects associated with long-term medication use.

Find a Location

Who is running the clinical trial?

Neurent MedicalLead Sponsor
4 Previous Clinical Trials
391 Total Patients Enrolled
4 Trials studying Chronic Rhinitis
391 Patients Enrolled for Chronic Rhinitis
Annalise SorensenStudy DirectorNeurent Medical
3 Previous Clinical Trials
259 Total Patients Enrolled
3 Trials studying Chronic Rhinitis
259 Patients Enrolled for Chronic Rhinitis

Media Library

NEUROMARK Treatment Clinical Trial Eligibility Overview. Trial Name: NCT05937308 — N/A
Chronic Rhinitis Research Study Groups: NEUROMARK Treatment
Chronic Rhinitis Clinical Trial 2023: NEUROMARK Treatment Highlights & Side Effects. Trial Name: NCT05937308 — N/A
NEUROMARK Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05937308 — N/A
~100 spots leftby Sep 2027