Clinical trial NCT05591989: Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects With Chronic Rhinitis (PARAGON)
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Rhinitis
Keywords: Rhinitis
Lead sponsor: Neurent Medical
Sponsor class: INDUSTRY
First posted: 2022-10-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, single-arm, multicenter clinical study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety
timeFrame: 24 months
measure: Efficacy
timeFrame: 6 months
Secondary outcomes:
measure: The mean change from baseline in rTNSS total score (except 6-month FU)
timeFrame: 24 months
measure: The mean change from baseline in rTNSS subscores
timeFrame: 24 months
measure: The mean change from baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ) score
timeFrame: 24 months
measure: The mean change from baseline in Clinical Global Impression -Improvement (CGI-I) score
timeFrame: 24 months
measure: Percent of subject satisfaction at follow-up
timeFrame: 24 months
measure: Tolerability of treatment via verbal report using the Numeric Rating Scale (NRS) score
timeFrame: 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Nasal and Sinus Center (Alabama Allergy)
state: Alabama
city: California City
country: United States
facility: Sacramento ENT
state: California
city: Temecula
country: United States
facility: United Medical Doctors
state: California
city: Colorado Springs
country: United States
facility: Colorado ENT
state: Colorado
city: Marrero
country: United States
facility: New Orleans Sinus Center
state: Louisiana
city: Baltimore
country: United States
facility: Centers for Advanced ENT Care (CAdENT)
state: Maryland
city: Royal Oak
country: United States
facility: Rontal Clinics
state: Michigan
city: Bethlehem
country: United States
facility: Specialty Physician Associates
state: Pennsylvania
city: Richmond
country: United States
facility: Richmond ENT
state: Virginia
city: Seattle
country: United States
facility: Ear Nose Throat & Allergy Associates
state: Washington
Study officials:
affiliation: Neurent Medical
name: Annalise Sorensen
role: STUDY_DIRECTOR
References: