Evaluation of Pulsed Field Ablation of the Posterior Nasal Nerve for Chronic Rhinitis
Aventix Medical Inc.
Summary
Evaluation of safety, effectiveness and tolerability of the Aventix Medical Device used for the treatment of chronic rhinitis
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…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- 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 eith…
Interventions
- DeviceNOVOCLEAR™ Device
Pulsed field energy applied to soft tissues in the nasal airway, including the posterior nasal nerve distribution.
Locations (3)
- Colorado ENT and AllergyColorado Springs, Colorado
- Bay Area ENTOcean Springs, Mississippi
- Atkins Expert Sinus CareSan Antonio, Texas