An interventional study of NOVOCLEAR™ Device in Chronic Rhinitis, sponsored by Aventix Medical Inc.. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Aventix Medical Inc. · Not applicable, Interventional, and Treatment
Evaluation of safety, effectiveness and tolerability of the Aventix Medical Device used for the treatment of chronic rhinitis
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.
246 studies on the registry are indexed under Rhinitis; 22 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 187 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →This is the only study on the registry with Aventix Medical Inc. as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: 90 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 90 days
Plan to share: Undecided
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