Effects of Radiofrequency Ablation of Posterior Nasal Nerves on Inflammatory Cytokines, Peak Nasal Inspiratory Flow, and Nasal Blood Flow in Patients With Chronic Rhinitis
NCT05648565 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2025-04-03
Summary
The purpose of this study is to assess the effectiveness of radiofrequency ablation (RFA) of the posterior nasal nerve (PNN) in chronic rhinitis (CR) patients by comparing patient reflective total nasal symptom score (rTNSS) and nasal obstruction symptom evaluation (NOSE) , peak nasal inspiratory flow (PNIF) , and levels of Type 2 cytokines pre- and post-procedure.
Conditions
- Chronic Rhinitis
Interventions
- DEVICE
-
Radiofrequency ablation (RFA)
The NEUROMARK device is an in-office, disposable bipolar RFA device with a treatment tip consisting of micro electrodes which delivers RF energy while monitoring appropriate tissue contact to maximize delivery to posterior nasal nerve and its variable branching. After topical anesthesia consisting of oxymetazoline and 1% lido followed by 4% lidocaine, the device will be placed in the posterior inferior turbinate under endoscopic visualization. The device will be activated per manufacturer's instructions
Sponsors & Collaborators
-
American Academy of Otolaryngic Allergy
collaborator OTHER -
The University of Texas Health Science Center, Houston
lead OTHER
Principal Investigators
-
David Z Allen, MD · The University of Texas Health Science Center, Houston
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-10
- Primary Completion
- 2024-02-20
- Completion
- 2024-02-20
- FDA Device
- Yes
Countries
- United States
Study Locations
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