NEUROMARK Randomized Controlled Trial

Completed · Not applicable · Has a placebo group

Conditions studied: Chronic Rhinitis

In brief

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

Key facts

Study ID

NCT06128200

Run by

Neurent Medical

People needed

132

Starts

2023-10-10

Expected to finish

2025-11-26

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant Must:
• Be ≥18 years of age.
• Have been experiencing rhinitis symptoms for a minimum of 6 months.
• 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.
• Be an appropriate candidate for bilateral NEUROMARK device treatment performed under local anesthesia.
• Be willing and able to comply with all study elements, as indicated by written informed consent.
• Primary Exclusion Criteria:
• Participant Must Not:
• 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.
• Have had previous sinus or nasal surgery within 6 months of study enrollment.
• Have previously undergone RF, cryotherapy, or other surgical interventions for rhinitis.
• Have rhinitis symptoms that are due to seasonal allergies only.

Where it is running

• 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

Full record on ClinicalTrials.gov

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