Clinical trial NCT06128200: NEUROMARK Randomized Controlled Trial
Official title: Randomized Controlled Trial Comparing NEUROMARK System to Sham Control in Patients With Chronic Rhinitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Rhinitis
Lead sponsor: Neurent Medical
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial
Primary purpose: TREATMENT

Brief summary: The NEUROMARK RCT Study is a prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial.


Eligibility criteria: Inclusion Criteria:

Participant 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. Be an appropriate candidate for bilateral NEUROMARK device treatment performed under local anesthesia.
5. Be willing and able to comply with all study elements, as indicated by written informed consent.

Primary Exclusion Criteria:

Participant 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 rhinitis symptoms that are due to seasonal allergies only.

Primary outcomes:
measure: rTNSS
timeFrame: 90-days post procedure follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Homewood
country: United States
facility: ExcelENT
state: Alabama
city: Opelika
country: United States
facility: East Alabama ENT
state: Alabama
city: Los Angeles
country: United States
facility: Sensa Health
state: California
city: Sacramento
country: United States
facility: Sacramento ENT
state: California
city: Torrance
country: United States
facility: Breathe Clear Institute
state: California
city: Boynton Beach
country: United States
facility: ENT & Allergy Associates of Florida
state: Florida
city: Port Saint Lucie
country: United States
facility: ENT & Allergy Associates of Florida
state: Florida
city: Anderson
country: United States
facility: Ascension St. Vincent
state: Indiana
city: Louisville
country: United States
facility: Kentuckiana
state: Kentucky
city: Louisville
country: United States
facility: Advanced ENT & Allergy
state: Kentucky
city: Baltimore
country: United States
facility: Centers for Advanced ENT Care
state: Maryland
city: Bethlehem
country: United States
facility: Bethlehem ENT
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist ENT Specialists
state: Texas
city: McKinney
country: United States
facility: The ENT & Allergy Centers of Texas
state: Texas
city: Richmond
country: United States
facility: Richmond ENT
state: Virginia
city: Puyallup
country: United States
facility: ENT & Allergy Associates
state: Washington
Study officials:
References: