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

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

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)

Study Overview

• Status: Enrolling by invitation
• Conditions: Chronic Rhinitis; Non-allergic Rhinitis
• Intervention / Treatment: Device: RhinAer; Device: Neuromark; Device: Clarifix

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Under 18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RhinAer; RhinAer is a radiofrequency ablation procedure for chronic rhinitis. This in-office procedure applies temperature-controlled radiofrequency energy to ablate the overactive posterior nasal nerve.	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.
Active Comparator: Neuromark; Neuromark is a radiofrequency ablation procedure for chronic rhinitis. This in-office procedure applies temperature-controlled radiofrequency energy to ablate the overactive posterior nasal nerve.	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.
Active Comparator: ClariFix; ClariFix is a cryoablation procedure for chronic rhinitis. This in-office procedure applies freezing (cryotherapy) to ablate the overactive posterior nasal nerve.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sino-Nasal Outcome Test-22 (SNOT-22)	SNOT-22 is a validated 22-item patient-reported outcome measure assessing sinonasal-specific quality of life across domains including nasal symptoms (nasal blockage, rhinorrhea, loss of smell/taste), ear and facial symptoms (ear pain, facial pressure), sleep dysfunction (difficulty falling asleep, waking up tired), and psychological and functional impairment (reduced productivity, fatigue, sadness).	SNOT-22 will be administered at baseline and at 1, 3, and 6 months post-procedure.
Total Nasal Symptom Score (TNSS)	TNSS is a validated 4-item patient-reported scoring instrument measuring severity of rhinorrhea, nasal congestion, nasal itching, and sneezing.	TNSS will be administered at baseline and at 1, 3, and 6 months post-procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) Patient Satisfaction	A 0-10 visual analog scale on which patients rate their overall satisfaction with the procedure and its effect on their chronic rhinitis symptoms, with higher scores indicating greater satisfaction.	VAS patient satisfaction will be administered at 1, 3, and 6 months post-procedure.

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cryotherapy; Radiofrequency ablation; Chronic rhinitis
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Picornaviridae Infections; Common Cold
• Other Study ID Numbers: #810809

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared outside the study team as this is an unfunded single-institution trial with no plans for external data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes