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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEUROMARK Treatment | Other | Interventional registry to collect real world data - Subjects will undergo treatment with the NEUROMARK System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEUROMARK System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | 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). | 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). | 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). | 30-month follow-up |
| Safety - incidence of device- and/or procedure-related serious adverse |
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Inclusion Criteria:
Subject MUST:
Exclusion Criteria:
Subjects Must Not:
1. Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
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| Name | Affiliation | Role |
|---|---|---|
| Annalise Sorensen | Neurent Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Nasal & Sinus Center | Birmingham | Alabama | 35242 | United States | ||
| Sensa Health |
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| ID | Term |
|---|---|
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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A Prospective, Multicenter, Single-arm, Post-market Interventional Registry. Collect real-world evidence.
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Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
| 36-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 | 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 | 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 | 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 | 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 | 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 | 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 | 36-month follow-up |
| Los Angeles |
| California |
| 90006 |
| United States |
| Sacramento ENT | Roseville | California | 95661 | United States |
| Florida ENT & Allergy | Brandon | Florida | 33511 | United States |
| ENT & Allergy Texas | McKinney | Texas | 75071 | United States |
| Ogden Clinic | Ogden | Utah | 84403 | United States |
| Metropolitan ENT | Alexandria | Virginia | 22310 | United States |
| D010038 |
| Otorhinolaryngologic Diseases |