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

NCT06598319 | Recruiting FDA Device

• 1 other identifier: A2024-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Chronic Rhinitis

Keywords

rhinitis, posterior nasal nerve

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Mean change in rTNSS at 7 days compared to baseline

  7 days

• Mean change in rTNSS at 14 days compared to baseline

  14 days

• Mean change in rTNSS at 30 days compared to baseline

  30 days

• Mean change in rTNSS at 6 months compared to baseline

  6 months

• Mean change in rTNSS at 1 year compared to baseline

  1 year

Study Arms (1)

NOVOCLEAR™ Device Treatment Group

EXPERIMENTAL

Subjects treated with pulsed field energy applied to soft tissues in the nasal airway, including the posterior nasal nerve distribution.

Device: NOVOCLEAR™ Device

Interventions

NOVOCLEAR™ Device DEVICE

Pulsed field energy applied to soft tissues in the nasal airway, including the posterior nasal nerve distribution.

NOVOCLEAR™ Device Treatment Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is 18 to 85 years of age.
• The subject has had symptoms of chronic rhinitis for greater than 6 months with insufficient response to nasal steroids.
• The subject has an rTNSS total score of ≥ 6.
• 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)
• The subject is able and willing to provide written informed consent and comply with the protocol requirements.

You may not qualify if:

• 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
• The subject has a septal perforation
• The subject has had prior sinus or nasal surgery on either side that significantly alters the anatomy of the posterior nose.
• The subject had had previous surgery of the PNN for chronic rhinitis.
• The subject has had prior head or neck irradiation
• The subject has an active or chronic nasal or sinus infection
• The subject has active coagulation disorder, or the patient is receiving anticoagulants
• The subject has a history of dry eye or dry nose symptoms
• Patient has rhinitis medicamentosa
• The subject has ocular allergic symptoms
• The subject has a history of nose bleeds
• The subject has electrically sensitive implants (e.g. cochlear implants, pacemakers, defibrillators)
• The subject is pregnant or lactating
• The subject is participating in another clinical research study
• The subject has an allergy or intolerance to anesthetic agent

Sponsors & Collaborators

• Aventix Medical Inc.: lead

Study Sites (3)

Colorado ENT and Allergy

Colorado Springs, Colorado, 80923, United States

RECRUITING

Bay Area ENT

Ocean Springs, Mississippi, 39564, United States

RECRUITING

Atkins Expert Sinus Care

San Antonio, Texas, 78256, United States

RECRUITING

MeSH Terms

Conditions

Rhinitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Raymond Weiss, MD

  Bay Area ENT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ClinicalAdmin

CONTACT

(510) 912-2589; clinical@aventixmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: November 15, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (3)