Recruiting

Aventix Device

Sponsor:

Aventix Medical Inc.

Code:

NCT06598319

Conditions

Chronic Rhinitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

NOVOCLEAR™ Device

Study Details

Brief summary:

Evaluation of safety, effectiveness and tolerability of the Aventix Medical Device used for the treatment of chronic rhinitis

Conditions

Chronic Rhinitis

Study ID

NCT06598319

Start date

Nov 15, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NOVOCLEAR™ Device Treatment Group

Subjects treated with pulsed field energy applied to soft tissues in the nasal airway, including the posterior nasal nerve distribution.

Interventions

NOVOCLEAR™ Device

Pulsed field energy applied to soft tissues in the nasal airway, including the posterior nasal nerve distribution.

Primary outcome measure

  • Mean change in Reflective Total Nasal Symptom Score (rTNSS) at 90 days compared to baseline. [ Time Frame: 90 days ]
  • Proportion of subjects with device and/or procedure-related serious adverse events through 90 days [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Locations

Colorado ENT and Allergy

Recruiting

Colorado Springs, Colorado, United States, 80923

Contacts

Monica Davis

(719) 867-7804

Principal Investigator:

Bryan Davis, MD

Bay Area ENT

Recruiting

Ocean Springs, Mississippi, United States, 39564

Atkins Expert Sinus Care

Recruiting

San Antonio, Texas, United States, 78256

More Information

Sponsor

Aventix Medical Inc.

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

  • rhinitis, posterior nasal nerve

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Aventix Medical Inc. on 2026-04-30.