Effects of Radiofrequency Ablation of Posterior Nasal Nerves on Inflammatory Cytokines, Peak Nasal Inspiratory Flow, and Nasal Blood Flow in Patients With Chronic Rhinitis
NCT ID: NCT05648565
Last Updated: 2025-04-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2023-01-10
2024-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Radiofrequency ablation (RFA)
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* rhinitis medicamentosa
* recurrent and ongoing epistaxis
* immunodeficiency as defined by an illness or a history of sinus surgery.
18 Years
80 Years
ALL
No
Sponsors
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American Academy of Otolaryngic Allergy
OTHER
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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David Z. Allen
Resident
Principal Investigators
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David Z Allen, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HSC-MS-22-0899
Identifier Type: -
Identifier Source: org_study_id
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