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

NCT07706595 | Enrolling By Invitation FDA Device

• 1 other identifier: #810809
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Chronic Rhinitis; Non-allergic Rhinitis

Keywords

Radiofrequency ablation; Cryotherapy; Chronic rhinitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Visual Analog Scale (VAS) Patient Satisfaction

  VAS patient satisfaction will be administered at 1, 3, and 6 months post-procedure.

Study Arms (3)

RhinAer

ACTIVE COMPARATOR

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

Neuromark

ACTIVE COMPARATOR

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

ClariFix

ACTIVE COMPARATOR

ClariFix is a cryoablation procedure for chronic rhinitis. This in-office procedure applies freezing (cryotherapy) to ablate the overactive posterior nasal nerve.

Device: Clarifix

Interventions

RhinAer DEVICE

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.

RhinAer

Neuromark DEVICE

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.

Neuromark

Clarifix DEVICE

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.

ClariFix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- Under 18 years of age

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (2)

Perlman Medical Office at UC San Diego

La Jolla, California, 92037, United States

Location

Veterans Affairs San Diego Healthcare System

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Of Clinical, Otolaryngology

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 16, 2026
• Study Start: July 18, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)