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Enrolling by invitation NCT07706595

A Randomized Controlled Trial Comparing Posterior Nasal Nerve Ablation Procedures for Chronic Rhinitis

No phase Interventional Chronic Rhinitis Non-allergic Rhinitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RhinAer, Neuromark, Clarifix.
Who it may be relevant to
Registry conditions: Chronic Rhinitis, Non-allergic Rhinitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Radiofrequency Ablation (RhinAer, Neuromark) vs. Cryoablation (ClariFix) of the Posterior Nasal Nerve for Chronic Rhinitis: A Randomized Controlled Trial

Overview

The goal of this clinical trial is to learn which procedural intervention most effectively reduces symptoms of chronic rhinitis (non-allergic rhinitis) in adult patients (18 years and older). The main questions it aims to answer are: * Which procedural intervention leads to the greatest reduction in total nasal symptom scores (TNSS)? * Which procedural intervention leads to the greatest improvement in sinonasal quality of life as measured by the SNOT-22? Researchers will compare radiofrequency ablation (RhinAer or Neuromark) and cryotherapy (ClariFix) to see if there are differences in symptom reduction and durability of response across treatments. Participants will: * Be randomly assigned to one of three FDA-cleared posterior nasal nerve ablation procedures (RhinAer, Neuromark, or ClariFix) * Complete validated symptom questionnaires (TNSS and SNOT-22) before and after their procedure * Have their relevant medical records reviewed (demographics, clinical history, prior rhinitis treatments)

Detailed description

Chronic rhinitis (non-allergic/vasomotor rhinitis) affects an estimated 14 million Americans and is characterized by nasal inflammation in the absence of infectious or allergic triggers. When medical management fails, patients may pursue procedural intervention to ablate the posterior nasal nerves. Currently available FDA-cleared standard-of-care options include in-office radiofrequency ablation (RhinAer, Neuromark) and cryotherapy (ClariFix). Despite the availability of these modalities, comparative effectiveness data are lacking. This randomized controlled trial will enroll adult patients and randomly assign them to one of the three treatment arms to compare symptom reduction and durability of response across the three procedures.

Interventions

  • Device RhinAer
    RhinAer is an in-office radiofrequency ablation device that delivers targeted thermal energy to the posterior nasal nerve along the lateral nasal wall. The procedure is performed under local anesthesia without the need for general anesthesia or sedation, and aims to reduce parasympathetic nerve signaling to decrease rhinorrhea, postnasal drip, and nasal congestion in patients with chronic rhinitis.
  • Device Neuromark
    Neuromark is an in-office radiofrequency ablation device that delivers targeted thermal energy to the posterior nasal nerve along the lateral nasal wall. The procedure is performed under local anesthesia without the need for general anesthesia or sedation, and aims to reduce parasympathetic nerve signaling to decrease rhinorrhea, postnasal drip, and nasal congestion in patients with chronic rhinitis.
  • Device Clarifix
    ClariFix is an in-office cryoablation device that applies freezing (cold thermal) energy to the posterior nasal nerve in the posterior nasal cavity. The procedure is performed under local anesthesia without the need for general anesthesia or sedation, and aims to reduce parasympathetic nerve signaling to decrease rhinorrhea, postnasal drip, and nasal congestion in patients with chronic rhinitis.

Primary outcome measures

  • Sino-Nasal Outcome Test-22 (SNOT-22) [Time frame: SNOT-22 will be administered at baseline and at 1, 3, and 6 months post-procedure.]
  • Total Nasal Symptom Score (TNSS) [Time frame: TNSS will be administered at baseline and at 1, 3, and 6 months post-procedure.]
Secondary outcome measures (1)
  • Visual Analog Scale (VAS) Patient Satisfaction [Time frame: VAS patient satisfaction will be administered at 1, 3, and 6 months post-procedure.]

Eligibility criteria

Inclusion criteria

  • Age 18 years or older
  • Diagnosis of chronic rhinitis (non-allergic rhinitis)

Exclusion criteria

\- Under 18 years of age

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Perlman Medical Office at UC San Diego — La Jolla
  • Veterans Affairs San Diego Healthcare System — San Diego

Identifiers

NCT: NCT07706595 · #810809

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗