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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be ≥18 years of age
Have moderate to severe symptoms of runny 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 baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90-days post procedure follow-up
Awards & highlights
Study Summary
This trial is researching a new treatment to help people with movement disorders.
Who is the study for?
This trial is for adults over 18 who've had a runny or stuffy nose from non-seasonal allergies for at least 6 months. They must be fit for the NEUROMARK treatment under local anesthesia and willing to follow the study's procedures. People with severe nasal structure issues, recent nasal surgery, or those treated before for rhinitis aren't eligible.Check my eligibility
What is being tested?
The NEUROMARK RCT Study is testing a new system designed to treat chronic rhinitis symptoms against a sham (fake) procedure. Participants won't know which they receive in this controlled test where treatments are assigned randomly.See study design
What are the potential side effects?
Possible side effects of the NEUROMARK System may include discomfort during treatment, temporary increase in nasal symptoms, bleeding, infection risk, and reactions to local anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have a runny nose and nasal congestion with a symptom score of at least 5 out of 12.
Select...
I have had symptoms of a runny or blocked nose for at least 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90-days post procedure follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90-days post procedure follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
rTNSS
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 Intervention
Subjects 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. Sham control participants will be offered the option to receive active treatment after the 90-day follow-up provided they still meet all eligibility criteria.
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Who is running the clinical trial?
Neurent MedicalLead Sponsor
4 Previous Clinical Trials
409 Total Patients Enrolled
4 Trials studying Chronic Rhinitis
409 Patients Enrolled for Chronic Rhinitis
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are included in this research endeavor?
"This trial necessitates 132 candidates who fit the predetermined qualifications. Patients can join in from Bethlehem ENT, located in Bethlehem, Pennsylvania and ENT & Allergy Associates in Puyallup, Washington."
Answered by AI
Is the enrollment period still open for this experimentation?
"The study, which was originally listed on October 10th 2023 has recently been updated (November 7th 2023) according to clinicaltrials.gov and is now actively recruiting participants."
Answered by AI
Are there any places within the state where this scientific trial is taking place?
"This trial has 5 participating sites, including Bethlehem ENT in Bethlehem, ENT & Allergy Associates in Puyallup and Sacramento ENT in Sacramento. Additionally, there are 2 other medical centres also involved."
Answered by AI
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