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NEUROMARK Randomized Controlled Trial

NCT06128200 — Not applicable, Completed, 132 participants, Neurent Medical

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Randomized Controlled Trial Comparing NEUROMARK System to Sham Control in Patients With Chronic Rhinitis

RegistryNCT06128200
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: single, treatment
Enrollment132 (Actual)
SponsorNeurent Medical (Industry)
ConditionsChronic Rhinitis
InterventionsNEUROMARK System, Sham NEUROMARK System (Device)
Datesstart 2023-10-10, primary completion 2025-11-26, completion 2025-11-26, first posted 2023-11-13, last updated 2026-03-19
Locations16 sites in United States

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-Summary

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

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+Arms and interventions

ArmTypeInterventionsDescription
ActiveActive comparatorDevice: NEUROMARK SystemSubjects in this arm will undergo treatment with the NEUROMARK device.
ShamSham comparatorDevice: Sham NEUROMARK SystemSubjects 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.
  • NEUROMARK System (Device): 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 (Device): Sham ablation procedure using the NEUROMARK System

+Outcome measures

Primary outcomes

  • rTNSS [90-days post procedure follow-up]: Comparison of the percentage of responders (participants with a 30% or greater reduction in rTNSS relative to baseline) between study arms at 90-days

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (16)

FacilityCityCountryStatus
ExcelENTHomewood, AlabamaUnited States
East Alabama ENTOpelika, AlabamaUnited States
Sensa HealthLos Angeles, CaliforniaUnited States
Sacramento ENTSacramento, CaliforniaUnited States
Breathe Clear InstituteTorrance, CaliforniaUnited States
ENT & Allergy Associates of FloridaBoynton Beach, FloridaUnited States
ENT & Allergy Associates of FloridaPort Saint Lucie, FloridaUnited States
Ascension St. VincentAnderson, IndianaUnited States
KentuckianaLouisville, KentuckyUnited States
Advanced ENT & AllergyLouisville, KentuckyUnited States
Centers for Advanced ENT CareBaltimore, MarylandUnited States
Bethlehem ENTBethlehem, PennsylvaniaUnited States
Houston Methodist ENT SpecialistsHouston, TexasUnited States
The ENT & Allergy Centers of TexasMcKinney, TexasUnited States
Richmond ENTRichmond, VirginiaUnited States
ENT & Allergy AssociatesPuyallup, WashingtonUnited States

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