Effects of Radiofrequency Ablation of Posterior Nasal Nerves on Inflammatory Cytokines, Peak Nasal Inspiratory Flow, and Nasal Blood Flow in Patients With Chronic Rhinitis

Chronic Rhinitis Clinical Trial

Official title:

Effects of Radiofrequency Ablation of Posterior Nasal Nerves on Inflammatory Cytokines, Peak Nasal Inspiratory Flow, and Nasal Blood Flow in Patients With Chronic Rhinitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05648565
• Other study ID #: HSC-MS-22-0899
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: David Z Allen, MD
• Phone: 713-500-5427
• Email: David.Allen[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinitis
• Rhinitis

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	American Academy of Otolaryngic Allergy & Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in nasal congestion as assessed by the peak nasal inspiratory flow (PNIF)	this directly measures nasal airflow during maximal inspiration in liters per minute	Baseline, 12 weeks post intervention
Primary	Change in levels of type 2 cytokines		Baseline,12 weeks post intervention
Secondary	Change in nasal congestion as assessed by the reflective total nasal symptom score (rTNSS)	This is a 4 item questionnaire and each is scored from 0(none) to 3(severe), with a maximum score of 12,a higher number indicating more congestion	Baseline,12 weeks post intervention
Secondary	Change in nasal obstruction as assessed by the nasal obstruction symptom evaluation survey (NOSE)	This is a 5 item self reported questionnaire and each is scored from 0(not a problem)-4(severe problem), with a maximum score of 20, a higher number indicating more obstruction	Baseline,12 weeks post intervention