Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The PARAGON Study is a prospective, single-arm, multicenter safety and efficacy study of the Neurent Medical NEUROMARK System in subjects with chronic rhinitis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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 |
|---|---|---|
| Change from Baseline in Total Reflective Total Nasal Symptom Score (rTNSS) at 6 Months [Efficacy] | The reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome assessing nasal congestion, rhinorrhea, sneezing, and nasal itching. Each symptom is scored from 0 (none) to 3 (severe), with a total score range of 0 to 12. A decrease in score indicates improvement in symptoms. | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants achieving ≥30% reduction from baseline in total rTNSS | Responder rate defined as the proportion of participants achieving a ≥30% reduction from baseline in total rTNSS score. | 6 months |
| Percentage of participants achieving minimal clinically important difference (MCID) in total rTNSS |
Not provided
Inclusion Criteria:
Subjects MUST:
Exclusion Criteria:
Subjects MUST NOT:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Annalise Sorensen | Neurent Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Nasal and Sinus Center (Alabama Allergy) | Birmingham | Alabama | 35242 | United States | ||
| Sacramento ENT |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41065547 | Derived | Yen DM, Davis GE, Ow RA, O'Malley EM, Del Signore AG. Two-Year Clinical Outcomes After Multipoint Impedance-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve for Treatment of Chronic Rhinitis. Ear Nose Throat J. 2025 Oct 9:1455613251382759. doi: 10.1177/01455613251382759. Online ahead of print. | |
| 39315465 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A prospective, single-arm, multicenter clinical study
Not provided
Not provided
Not provided
Not provided
MCID is defined as a reduction of ≥1 point from baseline in total rTNSS score. |
| 6 months |
| Change from baseline in total Nasal Obstruction Symptom Evaluation (NOSE) score | The NOSE score is a validated patient-reported outcome assessing nasal obstruction. Scores range from 0 to 100, with higher scores indicating worse symptoms. A decrease in total score indicates improvement. | Baseline to 6 months |
| Percentage of participants achieving response in total NOSE score | Responder rate defined as ≥20% improvement from baseline in total NOSE score or improvement of at least one NOSE severity class. | 6 months |
| Change from baseline in overall mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ) score | The mini-RQLQ is a validated patient-reported outcome assessing quality of life across multiple domains including activities, practical problems, nasal symptoms, eye symptoms, and other symptoms. Scores range from 0 to 6, with higher scores indicating worse quality of life. A decrease in overall score indicates improvement. | Baseline to 6 months |
| Percentage of participants achieving minimal clinically important difference (MCID) in overall mini-RQLQ | MCID is defined as a reduction of ≥0.4 points from baseline in the overall mini-RQLQ score. | 6 months |
| Change from baseline in overall Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) score | The ETDQ-7 is a patient-reported outcome assessing symptoms of Eustachian tube dysfunction. Scores range from 1 to 7, with higher scores indicating worse symptoms. A decrease in overall score indicates improvement. | Baseline to 6 months |
| Change from baseline in postnasal drip symptom score | Postnasal drip is assessed on a scale from 0 (none) to 3 (severe). A decrease from baseline indicates improvement in symptoms. | Baseline to 6 months |
| Change from baseline in cough symptom score | Cough is assessed on a scale from 0 (none) to 3 (severe). A decrease from baseline indicates improvement in symptoms. | Baseline to 6 months |
| Incidence of Device- and/or Procedure-Related Serious Adverse Events (SAEs) | The number of participants experiencing serious adverse events that are assessed as related to the device or procedure. | 6 months |
| California City |
| California |
| 95661 |
| United States |
| United Medical Doctors | Temecula | California | 92592 | United States |
| Colorado ENT | Colorado Springs | Colorado | 80923 | United States |
| New Orleans Sinus Center | Marrero | Louisiana | 70072 | United States |
| Centers for Advanced ENT Care (CAdENT) | Baltimore | Maryland | 21204 | United States |
| Rontal Clinics | Royal Oak | Michigan | 48073 | United States |
| Specialty Physician Associates | Bethlehem | Pennsylvania | 18017 | United States |
| Richmond ENT | Richmond | Virginia | 23235 | United States |
| Ear Nose Throat & Allergy Associates | Seattle | Washington | 98374-1145 | United States |
| Davis GE, Ow RA, Yen DM, O'Malley EM, Del Signore AG. Clinical Outcomes After Innovative Multipoint Impedance-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve for Treatment of Chronic Rhinitis. Ear Nose Throat J. 2024 Sep 24:1455613241285134. doi: 10.1177/01455613241285134. Online ahead of print. |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided