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

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05648565
• Collaborator: American Academy of Otolaryngic Allergy & Foundation (Other)
• Enrollment: 36
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 6.6
• Patients Per Site Per Month: 5.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Rhinitis	Device: Radiofrequency ablation (RFA)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jan 10, 2023
• Anticipated Primary Completion Date: Apr 15, 2023
• Anticipated Study Completion Date: Jul 30, 2023

Arms and Interventions

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

1. Change in nasal congestion as assessed by the peak nasal inspiratory flow (PNIF) [Baseline, 12 weeks post intervention]

   this directly measures nasal airflow during maximal inspiration in liters per minute

2. Change in levels of type 2 cytokines [Baseline,12 weeks post intervention]

Secondary Outcome Measures

1. Change in nasal congestion as assessed by the reflective total nasal symptom score (rTNSS) [Baseline,12 weeks post intervention]

   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

2. Change in nasal obstruction as assessed by the nasal obstruction symptom evaluation survey (NOSE) [Baseline,12 weeks post intervention]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston
• American Academy of Otolaryngic Allergy & Foundation

Investigators

• Principal Investigator: David Z Allen, MD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Z. Allen, Resident, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT05648565
• Other Study ID Numbers: HSC-MS-22-0899
• First Posted: Dec 13, 2022
• Last Update Posted: Jan 6, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by David Z. Allen, Resident, The University of Texas Health Science Center, Houston: radiofrequency ablation
• Additional relevant MeSH terms: Rhinitis

Study Results

No Results Posted as of Jan 6, 2023