Chronic Rhinitis
Conditions
Brief summary
The NEUROMARK RCT Study is a prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial.
Interventions
DEVICENEUROMARK System
The NEUROMARK System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis.
DEVICESham NEUROMARK System
Sham ablation procedure using the NEUROMARK System
Sponsors
Neurent Medical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
This is a single-blind study; participants will be blinded to the randomization assignment.
Intervention model description
A prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participant Must: 1. Be ≥18 years of age. 2. Have been experiencing rhinitis symptoms for a minimum of 6 months. 3. 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. 4. Be an appropriate candidate for bilateral NEUROMARK device treatment performed under local anesthesia. 5. Be willing and able to comply with all study elements, as indicated by written informed consent. Primary
Exclusion criteria
Participant Must Not: 1. Have clinically significant anatomic obstruction that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor. 2. Have had previous sinus or nasal surgery within 6 months of study enrollment. 3. Have previously undergone RF, cryotherapy, or other surgical interventions for rhinitis. 4. Have rhinitis symptoms that are due to seasonal allergies only.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rTNSS | 90-days post procedure follow-up | Comparison of the percentage of responders (participants with a 30% or greater reduction in rTNSS relative to baseline) between study arms at 90-days |
Countries
United States
Outcome results
None listed