Chronic Rhinitis
Conditions
Keywords
rhinitis, posterior nasal nerve
Brief summary
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.
Interventions
DEVICENOVOCLEAR™ Device
Pulsed field energy applied to soft tissues in the nasal airway, including the posterior nasal nerve distribution.
Sponsors
Aventix Medical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in Reflective Total Nasal Symptom Score (rTNSS) at 90 days compared to baseline. | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in rTNSS at 7 days compared to baseline | 7 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. |
| Mean change in rTNSS at 14 days compared to baseline | 14 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. |
| Mean change in rTNSS at 30 days compared to baseline | 30 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. |
| Mean change in rTNSS at 6 months compared to baseline | 6 months | 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. |
| Mean change in rTNSS at 1 year compared to baseline | 1 year | 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. |
| Mean procedure tolerability using a Visual Analogue Scale (VAS) at post-procedure | 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. |
| Subject satisfaction at 90 days | 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. |
Countries
United States
Contacts
CONTACTClinicalAdmin
PRINCIPAL_INVESTIGATORRaymond Weiss, MD
Bay Area ENT
Outcome results
None listed