Evaluation of Pulsed Field Ablation of the Posterior Nasal Nerve for Chronic Rhinitis

Evaluation of safety, effectiveness and tolerability of the Aventix Medical Device used for the treatment of chronic rhinitis

Study Overview

• Status: Recruiting
• Conditions: Chronic Rhinitis
• Intervention / Treatment: Device: NOVOCLEAR™ Device

Detailed Description

The NOVOCLEAR™ Device is a radiofrequency-based hand-held device intended to treat chronic rhinitis by delivering pulsed field energy to soft tissues in the nasal airway, including the posterior nasal nerve distribution. The NOVOCLEAR™ Device is used with the AVENTIX™ PFX System. The AVENTIX™ PFX System is a radiofrequency-based electrosurgical system designed to deliver non-thermal pulsed field energy to the targeted tissue.

This is a non-significant risk, prospective, multi-center, single arm study to evaluate the safety, effectiveness and tolerability of the NOVOCLEAR™ Device used with the AVENTIX™ PFX System.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ClinicalAdmin; Phone Number: (510) 912-2589; Email: clinical@aventixmed.com

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80923
      • Recruiting
      • Colorado ENT and Allergy
      • Principal Investigator: Bryan Davis, MD
      • Contact: Monica Davis; Phone Number: (719) 867-7804
  • Mississippi
    • Ocean Springs, Mississippi, United States, 39564
      • Recruiting
      • Bay Area ENT
      • Contact: Raymond Weiss, MD
  • Texas
    • San Antonio, Texas, United States, 78256
      • Recruiting
      • Atkins Expert Sinus Care
      • Contact: James Atkins, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The subject is 18 to 85 years of age.
2. The subject has had symptoms of chronic rhinitis for greater than 6 months with insufficient response to nasal steroids.
3. The subject has an rTNSS total score of ≥ 6.
4. The subject has had moderate to severe symptoms of rhinorrhea and/or nasal congestion (rTNSS rating of 2 or 3 for rhinorrhea and 1, 2, or 3 for congestion)
5. The subject is able and willing to provide written informed consent and comply with the protocol requirements.

Exclusion Criteria:

1. The subject has clinically significant anatomic obstructions on either side that limit access to the posterior nose, including severe septal deviation, nasal polyps, and sinonasal tumor
2. The subject has a septal perforation
3. The subject has had prior sinus or nasal surgery on either side that significantly alters the anatomy of the posterior nose.
4. The subject had had previous surgery of the PNN for chronic rhinitis.
5. The subject has had prior head or neck irradiation
6. The subject has an active or chronic nasal or sinus infection
7. The subject has active coagulation disorder, or the patient is receiving anticoagulants
8. The subject has a history of dry eye or dry nose symptoms
9. Patient has rhinitis medicamentosa
10. The subject has ocular allergic symptoms
11. The subject has a history of nose bleeds
12. The subject has electrically sensitive implants (e.g. cochlear implants, pacemakers, defibrillators)
13. The subject is pregnant or lactating
14. The subject is participating in another clinical research study
15. The subject has an allergy or intolerance to anesthetic agent
16. Any physical condition that, in the Investigator's opinion, would prevent adequate study participation or pose an increased risk

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NOVOCLEAR™ Device Treatment Group; Subjects treated with pulsed field energy applied to soft tissues in the nasal airway, including the posterior nasal nerve distribution.	Device: NOVOCLEAR™ Device; Pulsed field energy applied to soft tissues in the nasal airway, including the posterior nasal nerve distribution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in Reflective Total Nasal Symptom Score (rTNSS) at 90 days compared to baseline.	The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Total scores range from 0 to 12. A higher score indicates increased symptom severity.	90 days
Proportion of subjects with device and/or procedure-related serious adverse events through 90 days	Characterization of the type and frequency of study device and/or study procedure-related adverse events reported during or following the study procedure through 90 days follow-up.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in rTNSS at 7 days compared to baseline	The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Total scores range from 0 to 12. A higher score indicates increased symptom severity.	7 days
Mean change in rTNSS at 14 days compared to baseline	The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Total scores range from 0 to 12. A higher score indicates increased symptom severity.	14 days
Mean change in rTNSS at 30 days compared to baseline	The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Total scores range from 0 to 12. A higher score indicates increased symptom severity.	30 days
Mean change in rTNSS at 6 months compared to baseline	The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Total scores range from 0 to 12. A higher score indicates increased symptom severity.	6 months
Mean change in rTNSS at 1 year compared to baseline	The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Total scores range from 0 to 12. A higher score indicates increased symptom severity.	1 year
Mean procedure tolerability using a Visual Analogue Scale (VAS) at post-procedure	Immediately after the study procedure, subjects will be asked to rate the pain they experienced in their nasal cavity(ies) during the procedure using a 100 mm visual analogue scale with 0 mm representing no pain and 100 mm representing worst pain imaginable.	Post-procedure
Subject satisfaction at 90 days	Subjects will be asked two questions regarding their satisfaction with the study procedure. The first question asks; How satisfied with your procedure are you?; with the following five response options: very satisfied, satisfied, neutral, unsatisfied, or very unsatisfied. The second question asks; How likely are you to refer a friend for this procedure?; with the following five response options: very likely, likely, neutral, unlikely, or very unlikely.	90 days

Collaborators and Investigators

• Sponsor: Aventix Medical Inc.
• Investigators: Principal Investigator: Raymond Weiss, MD, Bay Area ENT

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: rhinitis, posterior nasal nerve
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis
• Other Study ID Numbers: A2024-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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