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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Pulsed field energy applied to soft tissues in the nasal airway, including the posterior nasal nerve distribution.
Colorado ENT and Allergy
Colorado Springs, Colorado, United States
RECRUITINGBay Area ENT
Ocean Springs, Mississippi, United States
RECRUITINGAtkins Expert Sinus Care
San Antonio, Texas, United States
RECRUITINGMean 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.
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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