RecruitingNot Applicable

Evaluation of Pulsed Field Ablation of the Posterior Nasal Nerve for Chronic Rhinitis

United States30 participantsStarted 2024-11-15

Plain-language summary

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

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)
✓. The subject is able and willing to provide written informed consent and comply with the protocol requirements.

✕. 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.
✕. The subject has had prior head or neck irradiation
✕. The subject has an active or chronic nasal or sinus infection
✕. The subject has active coagulation disorder, or the patient is receiving anticoagulants
✕. The subject has a history of dry eye or dry nose symptoms

Mean change in Reflective Total Nasal Symptom Score (rTNSS) at 90 days compared to baseline.

Timeframe: 90 days

Proportion of subjects with device and/or procedure-related serious adverse events through 90 days

Timeframe: 90 days

NCT IDNCT06598319

SponsorAventix Medical Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04

ClinicalAdmin

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)
✓. The subject is able and willing to provide written informed consent and comply with the protocol requirements.

✕. 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.
✕. The subject has had prior head or neck irradiation
✕. The subject has an active or chronic nasal or sinus infection
✕. The subject has active coagulation disorder, or the patient is receiving anticoagulants
✕. The subject has a history of dry eye or dry nose symptoms