CClinicalTrials.gg
CompletedNCT06128200Updated Mar 19, 2026

NEUROMARK Randomized Controlled Trial

An interventional study of NEUROMARK System and Sham NEUROMARK System in Chronic Rhinitis, sponsored by Neurent Medical. Completed at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Neurent Medical · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Chronic Rhinitis
03

In context

Lead sponsor

Neurent Medical is the lead sponsor of 6 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
132 participants (actual)

Study arms

  • Active comparator
    Active

    Subjects in this arm will undergo treatment with the NEUROMARK device.

    Device: NEUROMARK System

  • Sham comparator
    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.

    Device: Sham NEUROMARK System

Interventions

  • DeviceNEUROMARK 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.

  • DeviceSham NEUROMARK System

    Sham ablation procedure using the NEUROMARK System

06

What researchers measure

Primary outcomes

  1. rTNSS

    Comparison of the percentage of responders (participants with a 30% or greater reduction in rTNSS relative to baseline) between study arms at 90-days

    Time frame: 90-days post procedure follow-up

07

Study locations

16 sites
  • ExcelENT
    Homewood, Alabama 35204, United States
  • East Alabama ENT
    Opelika, Alabama 36801, United States
  • Sensa Health
    Los Angeles, California 90006, United States
  • Sacramento ENT
    Sacramento, California 95815, United States
  • Breathe Clear Institute
    Torrance, California 90503, United States
  • ENT & Allergy Associates of Florida
    Boynton Beach, Florida 33426, United States
  • ENT & Allergy Associates of Florida
    Port Saint Lucie, Florida 34952, United States
  • Ascension St. Vincent
    Anderson, Indiana 46016, United States
  • Kentuckiana
    Louisville, Kentucky 40205, United States
  • Advanced ENT & Allergy
    Louisville, Kentucky 40220, United States
  • Centers for Advanced ENT Care
    Baltimore, Maryland 21204, United States
  • Bethlehem ENT
    Bethlehem, Pennsylvania 18017, United States
  • Houston Methodist ENT Specialists
    Houston, Texas 77030, United States
  • The ENT & Allergy Centers of Texas
    McKinney, Texas 75708, United States
  • Richmond ENT
    Richmond, Virginia 23235, United States
  • ENT & Allergy Associates
    Puyallup, Washington 98374-1145, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06128200
Lead sponsor
Neurent Medical
Responsible party
Sponsor
First posted
Nov 13, 2023
Start date
Oct 10, 2023
Primary completion
Nov 26, 2025
Completion
Nov 26, 2025
Last update
Mar 19, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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