Effects of Radiofrequency Ablation of Posterior Nasal Nerves on Inflammatory Cytokines, Peak Nasal Inspiratory Flow, and Nasal Blood Flow in Patients With Chronic Rhinitis
Primary Purpose
Chronic Rhinitis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiofrequency ablation (RFA)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinitis focused on measuring radiofrequency ablation
Eligibility Criteria
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.
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiofrequency ablation (RFA)
Arm Description
Outcomes
Primary Outcome Measures
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
Change in levels of type 2 cytokines
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT05648565
First Posted
December 5, 2022
Last Updated
May 5, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
American Academy of Otolaryngic Allergy & Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05648565
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
American Academy of Otolaryngic Allergy & Foundation
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinitis
Keywords
radiofrequency ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radiofrequency ablation (RFA)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Radiofrequency ablation (RFA)
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in nasal congestion as assessed by the peak nasal inspiratory flow (PNIF)
Description
this directly measures nasal airflow during maximal inspiration in liters per minute
Time Frame
Baseline, 12 weeks post intervention
Title
Change in levels of type 2 cytokines
Time Frame
Baseline,12 weeks post intervention
Secondary Outcome Measure Information:
Title
Change in nasal congestion as assessed by the reflective total nasal symptom score (rTNSS)
Description
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
Time Frame
Baseline,12 weeks post intervention
Title
Change in nasal obstruction as assessed by the nasal obstruction symptom evaluation survey (NOSE)
Description
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
Time Frame
Baseline,12 weeks post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Z Allen, MD
Phone
713-500-5427
Email
David.Allen@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amber Luong
Phone
713-500-5410
Email
Amber.U.Luong@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Z Allen, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Z Allen, MD
Phone
713-500-5427
Email
David.Allen@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Amber Luong
Phone
713-500-5410
Email
Amber.U.Luong@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Radiofrequency Ablation of Posterior Nasal Nerves on Inflammatory Cytokines, Peak Nasal Inspiratory Flow, and Nasal Blood Flow in Patients With Chronic Rhinitis
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