Randomized Controlled Trial Comparing NEUROMARK System to Sham Control in Patients With Chronic Rhinitis
| Registry | NCT06128200 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: single, treatment |
| Enrollment | 132 (Actual) |
| Sponsor | Neurent Medical (Industry) |
| Conditions | Chronic Rhinitis |
| Interventions | NEUROMARK System, Sham NEUROMARK System (Device) |
| Dates | start 2023-10-10, primary completion 2025-11-26, completion 2025-11-26, first posted 2023-11-13, last updated 2026-03-19 |
| Locations | 16 sites in United States |
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The NEUROMARK RCT Study is a prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Active | Active comparator | Device: NEUROMARK System | Subjects in this arm will undergo treatment with the NEUROMARK device. |
| Sham | Sham comparator | Device: Sham NEUROMARK System | 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. |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| ExcelENT | Homewood, Alabama | United States | |
| East Alabama ENT | Opelika, Alabama | United States | |
| Sensa Health | Los Angeles, California | United States | |
| Sacramento ENT | Sacramento, California | United States | |
| Breathe Clear Institute | Torrance, California | United States | |
| ENT & Allergy Associates of Florida | Boynton Beach, Florida | United States | |
| ENT & Allergy Associates of Florida | Port Saint Lucie, Florida | United States | |
| Ascension St. Vincent | Anderson, Indiana | United States | |
| Kentuckiana | Louisville, Kentucky | United States | |
| Advanced ENT & Allergy | Louisville, Kentucky | United States | |
| Centers for Advanced ENT Care | Baltimore, Maryland | United States | |
| Bethlehem ENT | Bethlehem, Pennsylvania | United States | |
| Houston Methodist ENT Specialists | Houston, Texas | United States | |
| The ENT & Allergy Centers of Texas | McKinney, Texas | United States | |
| Richmond ENT | Richmond, Virginia | United States | |
| ENT & Allergy Associates | Puyallup, Washington | United States |