NCT05648565

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

January 10, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 3, 2025

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

December 5, 2022

Results QC Date

February 18, 2025

Last Update Submit

March 18, 2025

Conditions

Chronic Rhinitis

Keywords

radiofrequency ablation

Outcome Measures

Primary Outcomes (7)

  • Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)

    PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute.

    Baseline

  • Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)

    PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute

    4 weeks post intervention

  • Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)

    PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute

    12 weeks post intervention

  • Interleukin-10 (IL-10)

    cytokine

    Baseline

  • Interleukin-22 (IL-22)

    cytokine

    Baseline

  • Interleukin-10 (IL-10)

    cytokine

    12 weeks post intervention

  • Interleukin-22 (IL-22)

    cytokine

    12 weeks post intervention

Secondary Outcomes (6)

  • Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)

    Baseline

  • Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)

    4 weeks post intervention

  • Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)

    12 weeks post intervention

  • Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)

    Baseline

  • Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)

    4 weeks post intervention

  • +1 more secondary outcomes

Study Arms (1)

Radiofrequency ablation (RFA)

EXPERIMENTAL
Device: Radiofrequency ablation (RFA)

Interventions

Radiofrequency ablation (RFA)DEVICE

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

Radiofrequency ablation (RFA)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Results Point of Contact

Title
David Z. Allen
Organization
The University of Texas Health Science Center at Houston
David.Allen@uth.tmc.edu
713-500-5427

Study Officials

  • David Z Allen, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 13, 2022

Study Start

January 10, 2023

Primary Completion

February 20, 2024

Study Completion

February 20, 2024

Last Updated

April 3, 2025

Results First Posted

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)