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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • chronic rhinitis symptoms for at least 6 months (rhinorrhea, congestion, post-nasal drip) - poor response to medical management that was attempted for at least 4 weeks - a rTNSS score ≥6, as well as ≥2 for rhinorrhea, and ≥1 for congestion.

Exclusion Criteria

  • active sinusitis - rhinitis medicamentosa - recurrent and ongoing epistaxis - immunodeficiency as defined by an illness or a history of sinus surgery.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Radiofrequency ablation (RFA)
  • 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

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.