Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Under 18 years of age
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perlman Medical Office at UC San Diego | La Jolla | California | 92037 | United States | ||
| Veterans Affairs San Diego Healthcare System |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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. |
|
| San Diego |
| California |
| 92161 |
| United States |
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |