NCT Number: NCT07706595
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)
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Perlman Medical Office at UC San Diego, La Jolla, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: SNOT-22 will be administered at baseline and at 1, 3, and 6 months post-procedure.
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).
Time frame: TNSS will be administered at baseline and at 1, 3, and 6 months post-procedure.
TNSS is a validated 4-item patient-reported scoring instrument measuring severity of rhinorrhea, nasal congestion, nasal itching, and sneezing.
Time frame: VAS patient satisfaction will be administered at 1, 3, and 6 months post-procedure.
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.
University of California, San Diego
Other
Radiofrequency Ablation (RhinAer, Neuromark) vs. Cryoablation (ClariFix) of the Posterior Nasal Nerve for Chronic Rhinitis: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06599736
Chronic Rhinitis, Common Cold
Colorado Springs, Colorado, United States
View Trial DetailsNCT05324397
Chronic Rhinitis, Infections
Birmingham, Alabama, United States
View Trial DetailsNCT05591989
Chronic Rhinitis, Infections
Birmingham, Alabama, United States
View Trial DetailsNCT07323888
Airway Obstruction, Chronic Rhinitis
Chiayi City, Taiwan
View Trial Details