Clinical trial NCT05937308: NEUROMARK Registry Study
Official title: Interventional Registry to Collect Real-World Evidence of the NEUROMARK System in Subjects With Chronic Rhinitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Rhinitis
Keywords: Rhinitis
Lead sponsor: Neurent Medical
Sponsor class: INDUSTRY
First posted: 2023-07-10
Enrollment: 150
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, Multicenter, Single-arm, Post-market Interventional Registry. Collect real-world evidence.
Primary purpose: TREATMENT

Brief summary: The NEUROMARK Registry Study is a prospective, multicenter, single-arm, post-market, interventional registry study to collect real-world evidence of the NEUROMARK System in subjects with chronic rhinitis.


Eligibility criteria: Inclusion Criteria:

Subject MUST:

1. Be ≥18 years of age.
2. Be scheduled to receive treatment with the commercially available NEUROMARK System consistent with the device's indications for use.
3. Have moderate to severe symptoms of running 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 screening.
4. Be willing and able to provide consent and comply with all study elements, as indicated by written informed consent.

Exclusion Criteria:

Subjects Must Not:

1. Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.

Primary outcomes:
measure: Safety - incidence of device- and/or procedure-related serious adverse
timeFrame: 3-month follow-up
measure: Safety - incidence of device- and/or procedure-related serious adverse
timeFrame: 6-month follow-up
measure: Safety - incidence of device- and/or procedure-related serious adverse
timeFrame: 12-month follow-up
measure: Safety - incidence of device- and/or procedure-related serious adverse
timeFrame: 18-month follow-up
measure: Safety - incidence of device- and/or procedure-related serious adverse
timeFrame: 24-month follow-up
measure: Safety - incidence of device- and/or procedure-related serious adverse
timeFrame: 30-month follow-up
measure: Safety - incidence of device- and/or procedure-related serious adverse
timeFrame: 36-month follow-up
measure: Efficacy - reflective Total Nasal Symptom Score (rTNSS)
timeFrame: 3-month follow-up
measure: Efficacy - reflective Total Nasal Symptom Score (rTNSS)
timeFrame: 6-month follow-up
measure: Efficacy - reflective Total Nasal Symptom Score (rTNSS)
timeFrame: 12-month follow-up
measure: Efficacy - reflective Total Nasal Symptom Score (rTNSS)
timeFrame: 18-month follow-up
measure: Efficacy - reflective Total Nasal Symptom Score (rTNSS)
timeFrame: 24-month follow-up
measure: Efficacy - reflective Total Nasal Symptom Score (rTNSS)
timeFrame: 30-month follow-up
measure: Efficacy - reflective Total Nasal Symptom Score (rTNSS)
timeFrame: 36-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Nasal & Sinus Center
state: Alabama
city: Los Angeles
country: United States
facility: Sensa Health
state: California
city: Roseville
country: United States
facility: Sacramento ENT
state: California
city: Brandon
country: United States
facility: Florida ENT & Allergy
state: Florida
city: McKinney
country: United States
facility: ENT & Allergy Texas
state: Texas
city: Ogden
country: United States
facility: Ogden Clinic
state: Utah
city: Alexandria
country: United States
facility: Metropolitan ENT
state: Virginia
Study officials:
affiliation: Neurent Medical
name: Annalise Sorensen
role: STUDY_DIRECTOR
References: