Chronic RhinitisNCT07706595
A Randomized Controlled Trial Comparing Posterior Nasal Nerve Ablation Procedures for Chronic Rhinitis
A study testing RhinAer, Neuromark and Clarifix in people with Chronic Rhinitis and Non-allergic Rhinitis, run by University of California, San Diego at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinitis, Non-allergic Rhinitis
- What is being tested?
- RhinAer, Neuromark and Clarifix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jul 2024to 31 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Diagnosis of chronic rhinitis (non-allergic rhinitis)
Who cannot join
- Under 18 years of age
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Perlman Medical Office at UC San Diego
La Jolla, California, 92037
Veterans Affairs San Diego Healthcare System
San Diego, California, 92161
About this study
Official title: 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?
Read more
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)
Read the 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.
- Conditions
- Chronic Rhinitis, Non-allergic Rhinitis
- Being tested
- RhinAer, Neuromark, Clarifix
- Keywords
- Radiofrequency ablation, Cryotherapy, Chronic rhinitis
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhinAerDevice
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.
NeuromarkDevice
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.
ClarifixDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Clarifix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: TNSS will be administered at baseline and at 1, 3, and 6 months post-procedure.
Secondary outcomes (1)
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.
Measured: VAS patient satisfaction will be administered at 1, 3, and 6 months post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start18 Jul 2024
- Primary completion1 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carol Yan, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706595
- Sponsor's protocol ID
- #810809
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.