Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
132 participants
INTERVENTIONAL
2023-10-10
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Active
Subjects in this arm will undergo treatment with the NEUROMARK 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.
Sham
Subjects in this arm will undergo the procedure with a Sham device. Sham control participants will be offered the option to receive active treatment after the 90-day follow-up provided they still meet all eligibility criteria.
Sham NEUROMARK System
Sham ablation procedure using the NEUROMARK System
Interventions
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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.
Sham NEUROMARK System
Sham ablation procedure using the NEUROMARK System
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Neurent Medical
INDUSTRY
Responsible Party
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Locations
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ExcelENT
Homewood, Alabama, United States
East Alabama ENT
Opelika, Alabama, United States
Sensa Health
Los Angeles, California, United States
Sacramento ENT
Sacramento, California, United States
Breathe Clear Institute
Torrance, California, United States
ENT & Allergy Associates of Florida
Boynton Beach, Florida, United States
ENT & Allergy Associates of Florida
Port Saint Lucie, Florida, United States
Ascension St. Vincent
Anderson, Indiana, United States
Kentuckiana
Louisville, Kentucky, United States
Advanced ENT & Allergy
Louisville, Kentucky, United States
Centers for Advanced ENT Care
Baltimore, Maryland, United States
Bethlehem ENT
Bethlehem, Pennsylvania, United States
Houston Methodist ENT Specialists
Houston, Texas, United States
The ENT & Allergy Centers of Texas
McKinney, Texas, United States
Richmond ENT
Richmond, Virginia, United States
ENT & Allergy Associates
Puyallup, Washington, United States
Countries
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Other Identifiers
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CIP-0010
Identifier Type: -
Identifier Source: org_study_id
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