Chronic Rhinitis
Conditions
Keywords
Rhinitis
Brief summary
The PARAGON Study is a prospective, single-arm, multicenter safety and efficacy study of the Neurent Medical NEUROMARK System in subjects with chronic rhinitis.
Interventions
DEVICENEUROMARK System
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.
Sponsors
Neurent Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective, single-arm, multicenter clinical study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects 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. Have an allergy test (by skin prick or intradermal testing, or by a validated in vitroImmunoglobin E \[IgE test\]) on file within 5 years of the baseline visit or is willing to have one performed during the study prior to 6-month visit. 5. Be an appropriate candidate for bilateral NEUROMARK® device treatment performed under local anesthesia. 6. Test negative for active COVID-19 at the start of the study screening and continue to be free of COVID-19 symptoms until the time of enrollment/treatment. 7. Be willing and able to comply with all study elements, as indicated by written informed consent.
Exclusion criteria
Subjects 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 an active nasal or sinus infection. 5. Have nasal mucosal erosion/ulceration. 6. Have rhinitis symptoms that are due to seasonal allergies only. 7. Have plans to (or otherwise anticipates the need to) undergo an ENT procedure concurrently or within 6 months after the study procedure. 8. Have started a new sinonasal medication regimen within 4 weeks prior to treatment that, according to the manufacturer's labelling, has not yet stabilized. 9. Be on prescribed anticoagulants (eg, warfarin, Plavix) or ≥ 325 mg aspirin that cannot be held for an appropriate time before the procedure. 10. Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months. 11. Have numbness of the soft palate, excessive dry eye, excessive dry nose, or other indication of neuro/nerve compromise in the sinonasal cavity. 12. Have an active rhinitis medicamentosa or a history of rhinitis medicamentosa within the past 6 months. 13. Have been diagnosed with atrophic rhinitis. 14. Have had previous head and/or neck irradiation. 15. Have an allergy or intolerance to local anesthetic agents. 16. Be pregnant. 17. Have a physical, neurological, medical, psychiatric condition or situation that, in the investigator's opinion, puts the subject at risk, could confound the study results, or may interfere significantly with the subject's participation in the study. 18. Be participating in another clinical research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Total Reflective Total Nasal Symptom Score (rTNSS) at 6 Months [Efficacy] | Baseline to 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants achieving ≥30% reduction from baseline in total rTNSS | 6 months | Responder rate defined as the proportion of participants achieving a ≥30% reduction from baseline in total rTNSS score. |
| Percentage of participants achieving minimal clinically important difference (MCID) in total rTNSS | 6 months | MCID is defined as a reduction of ≥1 point from baseline in total rTNSS score. |
| Change from baseline in total Nasal Obstruction Symptom Evaluation (NOSE) score | Baseline to 6 months | 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. |
| Percentage of participants achieving response in total NOSE score | 6 months | Responder rate defined as ≥20% improvement from baseline in total NOSE score or improvement of at least one NOSE severity class. |
| Change from baseline in overall mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ) score | Baseline to 6 months | 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. |
| Percentage of participants achieving minimal clinically important difference (MCID) in overall mini-RQLQ | 6 months | MCID is defined as a reduction of ≥0.4 points from baseline in the overall mini-RQLQ score. |
| Change from baseline in overall Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) score | Baseline to 6 months | 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. |
| Change from baseline in postnasal drip symptom score | Baseline to 6 months | Postnasal drip is assessed on a scale from 0 (none) to 3 (severe). A decrease from baseline indicates improvement in symptoms. |
| Change from baseline in cough symptom score | Baseline to 6 months | Cough is assessed on a scale from 0 (none) to 3 (severe). A decrease from baseline indicates improvement in symptoms. |
| Incidence of Device- and/or Procedure-Related Serious Adverse Events (SAEs) | 6 months | The number of participants experiencing serious adverse events that are assessed as related to the device or procedure. |
Countries
United States
Contacts
STUDY_DIRECTORAnnalise Sorensen
Neurent Medical
Outcome results
None listed