Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects With Chronic Rhinitis (PARAGON)

Chronic Rhinitis Clinical Trial

Official title:

Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects With Chronic Rhinitis (PARAGON) - A Prospective, Single-arm, Multicenter Clinical Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05591989
• Other study ID #: CIP-0007
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 26, 2022
• Est. completion date: June 2025

Study information

• Verified date: April 2023
• Source: Neurent Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinitis
• Rhinitis

Intervention

Device:
• NEUROMARK 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.

Locations

Country	Name	City	State
United States	Centers for Advanced ENT Care (CAdENT)	Baltimore	Maryland
United States	Specialty Physician Associates	Bethlehem	Pennsylvania
United States	Alabama Nasal and Sinus Center (Alabama Allergy)	Birmingham	Alabama
United States	Sacramento ENT	California City	California
United States	Colorado ENT	Colorado Springs	Colorado
United States	New Orleans Sinus Center	Marrero	Louisiana
United States	Richmond ENT	Richmond	Virginia
United States	Rontal Clinics	Royal Oak	Michigan
United States	Ear Nose Throat & Allergy Associates	Seattle	Washington
United States	United Medical Doctors	Temecula	California

Sponsors (1)

Lead Sponsor	Collaborator
Neurent Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Safety, as assessed by the incidence of device- and/or procedure related serious adverse events (SAEs)	24 months
Primary	Efficacy	Efficacy, as assessed by the mean change from baseline in nasal symptoms using the 4-symptom rTNSS (reflective Total Nasal Symptom Score) at 6-month follow-up (FU)	6 months
Secondary	The mean change from baseline in rTNSS total score (except 6-month FU)	The mean change from baseline in rTNSS total score (except 6-month FU)	24 months
Secondary	The mean change from baseline in rTNSS subscores	The mean change from baseline in rTNSS subscores	24 months
Secondary	The mean change from baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ) score	The mean change from baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ) score	24 months
Secondary	The mean change from baseline in Clinical Global Impression -Improvement (CGI-I) score	The mean change from baseline in Clinical Global Impression -Improvement (CGI-I) score	24 months
Secondary	Percent of subject satisfaction at follow-up	Percent of subject satisfaction at follow-up	24 months
Secondary	Tolerability of treatment via verbal report using the Numeric Rating Scale (NRS) score	Tolerability of treatment via verbal report using the Numeric Rating Scale (NRS) score	24 months