Trial Outcomes & Findings for 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 NCT05648565)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

Baseline

Results posted on

2025-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	17
Overall Study Received Intervention	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiofrequency Ablation (RFA) n=17 Participants 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
Age, Continuous	62.18 years STANDARD_DEVIATION 14.6 • n=17 Participants
Sex: Female, Male Female	8 Participants n=17 Participants
Sex: Female, Male Male	9 Participants n=17 Participants
Region of Enrollment United States	17 participants n=17 Participants

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation (RFA) n=15 Participants 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
Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)	90 Liters Per Minute Interval 66.6 to 113.4

PRIMARY outcome

Timeframe: 4 weeks post intervention

Population: Data were not collected from 6 participants in the Radiofrequency ablation (RFA) arm.

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

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation (RFA) n=11 Participants 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
Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)	85 Liters Per Minute Interval 46.9 to 123.1

PRIMARY outcome

Timeframe: 12 weeks post intervention

Population: Data were not collected from 5 participants in the Radiofrequency ablation (RFA) arm.

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

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation (RFA) n=12 Participants 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
Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)	85 Liters Per Minute Interval 58.1 to 111.9

PRIMARY outcome

Timeframe: Baseline

cytokine

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation (RFA) n=15 Participants 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
Interleukin-10 (IL-10)	1.63 picogram per milliliter (pg/mL) Standard Deviation 4.28

PRIMARY outcome

Timeframe: Baseline

cytokine

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation (RFA) n=15 Participants 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
Interleukin-22 (IL-22)	0.45 picogram per milliliter (pg/mL) Standard Deviation 1.22

PRIMARY outcome

Timeframe: 12 weeks post intervention

cytokine

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation (RFA) n=13 Participants 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
Interleukin-10 (IL-10)	9.05 picogram per milliliter (pg/mL) Standard Deviation 38.06

PRIMARY outcome

Timeframe: 12 weeks post intervention

Population: cytokine

cytokine

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation (RFA) n=13 Participants 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
Interleukin-22 (IL-22)	0.37 picogram per milliliter (pg/mL) Standard Deviation 3.13

SECONDARY outcome

Timeframe: Baseline

This is a 4 item questionnaire and each is scored from 0(none) to 3(severe). The sum of the 4 times were added to generate a scale from 0 to 12, a higher number indicating more congestion

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation (RFA) n=15 Participants 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
Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)	7 score on a scale Interval 2.9 to 5.1

SECONDARY outcome

Timeframe: 4 weeks post intervention

Population: Data were not collected from 6 participants in the Radiofrequency ablation (RFA) arm.

This is a 4 item questionnaire and each is scored from 0(none) to 3(severe). The sum of the 4 times were added to generate a scale from 0 to 12, a higher number indicating more congestion

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation (RFA) n=11 Participants 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
Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)	4 score on a scale Interval 2.8 to 5.3

SECONDARY outcome

Timeframe: 12 weeks post intervention

Population: Data were not collected from 5 participants in the Radiofrequency ablation (RFA) arm.

This is a 4 item questionnaire and each is scored from 0(none) to 3(severe). The sum of the 4 times were added to generate a scale from 0 to 12, a higher number indicating more congestion

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation (RFA) n=12 Participants 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
Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)	4 score on a scale Interval 2.0 to 6.0

SECONDARY outcome

Timeframe: Baseline

This is a 5 item self reported questionnaire and each is scored from 0(not a problem) - 4(severe problem). The sum of the 5 items were multiplied by 5, to generate a scale from 0 to 100, a higher score indicated more obstruction.

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation (RFA) n=15 Participants 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
Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)	50 score on a scale Interval 30.0 to 70.0

SECONDARY outcome

Timeframe: 4 weeks post intervention

Population: Data were not collected from 6 participants in the Radiofrequency ablation (RFA) arm.

This is a 5 item self reported questionnaire and each is scored from 0(not a problem) - 4(severe problem). The sum of the 5 items were multiplied by 5, to generate a scale from 0 to 100, a higher score indicated more obstruction.

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation (RFA) n=11 Participants 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
Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)	10 score on a scale Interval 0.0 to 22.5

SECONDARY outcome

Timeframe: 12 weeks post intervention

Population: Data were not collected from 5 participants in the Radiofrequency ablation (RFA) arm.

This is a 5 item self reported questionnaire and each is scored from 0(not a problem) - 4(severe problem). The sum of the 5 items were multiplied by 5, to generate a scale from 0 to 100, a higher score indicated more obstruction.

Outcome measures

Outcome measures
Measure	Radiofrequency Ablation (RFA) n=12 Participants 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
Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)	17.5 score on a scale Interval 0.0 to 28.1

Adverse Events

Radiofrequency Ablation (RFA)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Radiofrequency Ablation (RFA) n=17 participants at risk 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
General disorders Headaches	17.6% 3/17 • 12 weeks
Infections and infestations dental infection	5.9% 1/17 • 12 weeks

Additional Information

David Z. Allen

The University of Texas Health Science Center at Houston

Phone: 713-500-5427

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place