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The NEUROMARK RCT Study is a prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Subjects in this arm will undergo treatment with the NEUROMARK device. |
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| Sham | Sham Comparator | 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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| 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 |
|---|---|---|
| rTNSS | Comparison of the percentage of responders (participants with a 30% or greater reduction in rTNSS relative to baseline) between study arms at 90-days | 90-days post procedure follow-up |
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Inclusion Criteria:
Participant Must:
Primary Exclusion Criteria:
Participant Must Not:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ExcelENT | Homewood | Alabama | 35204 | United States | ||
| East Alabama ENT |
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A prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial
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This is a single-blind study; participants will be blinded to the randomization assignment.
| Sham NEUROMARK System | Device | Sham ablation procedure using the NEUROMARK System |
|
| Opelika |
| Alabama |
| 36801 |
| United States |
| Sensa Health | Los Angeles | California | 90006 | United States |
| Sacramento ENT | Sacramento | California | 95815 | United States |
| Breathe Clear Institute | Torrance | California | 90503 | United States |
| ENT & Allergy Associates of Florida | Boynton Beach | Florida | 33426 | United States |
| ENT & Allergy Associates of Florida | Port Saint Lucie | Florida | 34952 | United States |
| Ascension St. Vincent | Anderson | Indiana | 46016 | United States |
| Kentuckiana | Louisville | Kentucky | 40205 | United States |
| Advanced ENT & Allergy | Louisville | Kentucky | 40220 | United States |
| Centers for Advanced ENT Care | Baltimore | Maryland | 21204 | United States |
| Bethlehem ENT | Bethlehem | Pennsylvania | 18017 | United States |
| Houston Methodist ENT Specialists | Houston | Texas | 77030 | United States |
| The ENT & Allergy Centers of Texas | McKinney | Texas | 75708 | United States |
| Richmond ENT | Richmond | Virginia | 23235 | United States |
| ENT & Allergy Associates | Puyallup | Washington | 98374-1145 | United States |