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New treatment option for Chronic Rhinitis
Official title Evaluation of Pulsed Field Ablation of the Posterior Nasal Nerve for Chronic Rhinitis
ClinicalTrials.gov ID: NCT06598319
What this study is testing
- What it's testing
- Evaluation of safety, effectiveness and tolerability of the Aventix Medical Device used for the treatment of chronic rhinitis
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
- The subject is able and willing to provide written informed consent and comply with the protocol requirements.
You likely can't join if
- The subject has clinically significant anatomic obstructions on either side that limit access to the posterior nose, including severe septal...
- 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
See the full eligibility criteria
- 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
- Patient has rhinitis medicamentosa
- The subject has ocular allergic symptoms
- The subject has a history of nose bleeds
- The subject has electrically sensitive implants (e.g. cochlear implants, pacemakers, defibrillators)
- The subject is pregnant or lactating
- The subject is participating in another clinical research study
- The subject has an allergy or intolerance to anesthetic agent
- Any physical condition that, in the Investigator's opinion, would prevent adequate study participation or pose an increased risk
The study team makes the final eligibility decision.
Where it's taking place
- Colorado Springs, Colorado, United States
- Ocean Springs, Mississippi, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colorado Springs, Colorado, United States; Ocean Springs, Mississippi, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.