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Neurostimulation Device
Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis (MERIDIEN Trial)
N/A
Waitlist Available
Research Sponsored by Neurent Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Summary
This trial is testing the NEUROMARK™ System, a device for treating people with chronic rhinitis. It aims to help those who have ongoing symptoms by using electrical signals to reduce inflammation in the nose.
Eligible Conditions
- Hay Fever
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Frequency of Serious Adverse Events (SAEs) directly attributable to the device
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Subject in this arm will undergo treatment with the NEUROMARK device.
Group II: ShamPlacebo Group1 Intervention
Subjects in this arm will undergo the procedure with a Sham device. At 3 months post treatment these subjects will cross over to Arm 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NEUROMARK™ System
2021
N/A
~150
Find a Location
Who is running the clinical trial?
Neurent MedicalLead Sponsor
4 Previous Clinical Trials
398 Total Patients Enrolled
Annalise SorensenStudy DirectorNeurent Medical
3 Previous Clinical Trials
266 Total Patients Enrolled