NEUROMARK Registry Study

Last updated: January 23, 2025
Sponsor: Neurent Medical
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Common Cold

Allergy

Nasal Obstruction

Treatment

NEUROMARK System

Clinical Study ID

NCT05937308
CIP-0008
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

Subject MUST:

  1. Be ≥18 years of age.

  2. Be scheduled to receive treatment with the commercially available NEUROMARK Systemconsistent 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 symptomrating 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, asindicated by written informed consent.

Exclusion

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.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: NEUROMARK System
Phase:
Study Start date:
June 12, 2023
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Alabama Nasal & Sinus Center

    Birmingham, Alabama 35242
    United States

    Site Not Available

  • Sensa Health

    Los Angeles, California 90006
    United States

    Site Not Available

  • Sacramento ENT

    Roseville, California 95661
    United States

    Site Not Available

  • Florida ENT & Allergy

    Brandon, Florida 33511
    United States

    Site Not Available

  • ENT & Allergy Texas

    McKinney, Texas 75071
    United States

    Site Not Available

  • Ogden Clinic

    Ogden, Utah 84403
    United States

    Site Not Available

  • Metropolitan ENT

    Alexandria, Virginia 22310
    United States

    Site Not Available

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