Evaluation of Pulsed Field Ablation of the Posterior Nasal Nerve for Chronic Rhinitis
ConditionChronic Rhinitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAventix Medical Inc.
About this trial
Evaluation of safety, effectiveness and tolerability of the Aventix Medical Device used for the treatment of chronic rhinitis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
NOVOCLEAR™ Device
DevicePulsed field energy applied to soft tissues in the nasal airway, including the posterior nasal nerve distribution.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: NOVOCLEAR™ Device Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 days2
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 daysSecondary outcomes
1
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 days2
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 days3
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 days4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov