N/A
N=30
Multi-Treatment PNN Modulation for Chronic Rhinitis
Chronic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT03791489 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Number of Participants With Procedure-related Serious Adverse Events (SAEs) and/or Serious Adverse Device Effects (SADE) — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ClariFix (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Arrinex, Inc.
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Procedure-related Serious Adverse Events (SAEs) and/or Serious Adverse Device Effects (SADE) |
— | — |
| SECONDARY Pain Scores |
1.0; 4.1 | — |
| SECONDARY Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS) |
-3.5; -4.0 | <0.0001 sig |
| SECONDARY Change From Baseline in the Overall Nasal Obstruction Symptom Evaluation (NOSE) Score |
-19.0; -31.4 | <0.03 sig |
Summary
Feasibility of treatment at multiple sites with the ClariFix cryoablation device for treatment of chronic rhinitis
Eligibility Criteria
Inclusion Criteria
- Presence of moderate to severe rhinorrhea symptoms and mild to severe nasal congestion symptoms for >3 months.
- Documented allergy test within the last 10 years that defines whether or not subject has allergies to perennial and seasonal allergens, or is willing to have one performed prior to study exit.
- Able to provide informed consent and willing to complete study activities and visits per protocol.
Exclusion Criteria
- Clinically significant anatomic obstructions that limit access to the posterior nose.
- Prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose.
- Moderate to severe ocular symptoms as determined.
- History of epistaxis in the past 3 months.
- History of rhinitis medicamentosa.
- Prior head or neck irradiation.
- Active or chronic nasal or sinus infection.
- Pregnant.
- Allergy or intolerance to anesthetic agent.
- Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or, open and/or infected wounds at or near the target tissue.
- Currently participating in another clinical research study.
- Any physical condition that, in the investigator's opinion, would prevent adequate study participation or pose increased risk.
Data sourced from ClinicalTrials.gov (NCT03791489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.