Chronic RhinitisNCT06598319
Evaluation of Pulsed Field Ablation of the Posterior Nasal Nerve for Chronic Rhinitis
A study testing NOVOCLEAR™ Device in people with Chronic Rhinitis, run by Aventix Medical Inc. at 3 sites in United States.
Trial summary
Evaluation of safety, effectiveness and tolerability of the Aventix Medical Device used for the treatment of chronic rhinitis Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Rhinitis
- What is being tested?
- NOVOCLEAR™ Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Nov 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
- Any physical condition that, in the Investigator's opinion, would prevent adequate study participation or pose an increased risk
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Colorado ENT and Allergy
Colorado Springs, Colorado, 80923
Monica Davis, (719) 867-7804
Bryan Davis, MD
- Recruiting
Bay Area ENT
Ocean Springs, Mississippi, 39564
Raymond Weiss, MD
- Recruiting
Atkins Expert Sinus Care
San Antonio, Texas, 78256
James Atkins, MD
About this study
Evaluation of safety, effectiveness and tolerability of the Aventix Medical Device used for the treatment of chronic rhinitis
Read the 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.
- Conditions
- Chronic Rhinitis
- Being tested
- NOVOCLEAR™ Device
- Keywords
- rhinitis, posterior nasal nerve
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOVOCLEAR™ DeviceDevice
Pulsed field energy applied to soft tissues in the nasal airway, including the posterior nasal nerve distribution.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: NOVOCLEAR™ Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 90 days
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Nov 2024
- Primary completionApr 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aventix Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raymond Weiss, MD, Principal investigator, Bay Area ENT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598319
- Sponsor's protocol ID
- A2024-01
- Status last verified
- Apr 2026
- First submitted
- 13 Sep 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pulsed Field Ablation of the Posterior Nasal Nerve for Chronic Rhinitis
- ClinicalTrials.gov ID
- NCT06598319
- Acronym / sponsor ID
- A2024-01
- Conditions
- Chronic Rhinitis
- Keywords
- rhinitis, posterior nasal nerve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aventix Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of safety, effectiveness and tolerability of the Aventix Medical Device used for the treatment of chronic rhinitis
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOVOCLEAR™ Device Treatment Group | Experimental | Device: NOVOCLEAR™ DeviceSubjects treated with pulsed field energy applied to soft tissues in the nasal airway, including the posterior nasal nerve distribution. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOVOCLEAR™ DevicePulsed field energy applied to soft tissues in the nasal airway, including the posterior nasal nerve distribution. | Device | NOVOCLEAR™ Device Treatment Group |
Primary outcome
Mean change in Reflective Total Nasal Symptom Score (rTNSS) at 90 days compared to baseline.
Time frame: 90 days
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.
Proportion of subjects with device and/or procedure-related serious adverse events through 90 days
Time frame: 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.
7 secondary outcomes
Mean change in rTNSS at 7 days compared to baseline
Time frame: 7 days
Mean change in rTNSS at 14 days compared to baseline
Time frame: 14 days
Mean change in rTNSS at 30 days compared to baseline
Time frame: 30 days
Mean change in rTNSS at 6 months compared to baseline
Time frame: 6 months
Mean change in rTNSS at 1 year compared to baseline
Time frame: 1 year
Mean procedure tolerability using a Visual Analogue Scale (VAS) at post-procedure
Time frame: Post-procedure
Subject satisfaction at 90 days
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raymond Weiss, MD principal investigator
Bay Area ENT
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOVOCLEAR™ Device in people with Chronic Rhinitis, run by Aventix Medical Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ClinicalAdmin ((510) 912-2589, clinical@aventixmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in Reflective Total Nasal Symptom Score (rTNSS) at 90 days compared to baseline. (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.