Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
study ends around
Principal Investigator
by Carol Yan

Description

Summary

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)

Official Title

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

Details

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.

Keywords

Chronic Rhinitis, Non-allergic Rhinitis, Radiofrequency ablation, Cryotherapy, Common Cold, RhinAer, Neuromark, Clarifix

Eligibility

You can join if…

Open to people ages 18 years and up

You CAN'T join if...

  • Under 18 years of age

Locations

  • Perlman Medical Office at UC San Diego
    La Jolla California 92037 United States
  • Veterans Affairs San Diego Healthcare System
    San Diego California 92161 United States

Lead Scientist at UCSD

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT07706595
Study Type
Interventional
Participants
Expecting 50 study participants
Last Updated