The NEUROMARK Registry Study is a prospective, multicenter, single-arm, post-market, interventional registry study to collect real-world evidence of the NEUROMARK System in subjects with chronic rhinitis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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.
Alabama Nasal & Sinus Center
Birmingham, Alabama, United States
Sensa Health
Los Angeles, California, United States
Sacramento ENT
Roseville, California, United States
Florida ENT & Allergy
Brandon, Florida, United States
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Time frame: 3-month follow-up
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Time frame: 6-month follow-up
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Time frame: 12-month follow-up
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Time frame: 18-month follow-up
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Time frame: 24-month follow-up
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Time frame: 30-month follow-up
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Time frame: 36-month follow-up
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ENT & Allergy Texas
McKinney, Texas, United States
Ogden Clinic
Ogden, Utah, United States
Metropolitan ENT
Alexandria, Virginia, United States
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Time frame: 3-month follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Time frame: 6-month follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Time frame: 12-month follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Time frame: 18-month follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Time frame: 24-month follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Time frame: 30-month follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Time frame: 36-month follow-up