N/A
Completed N=27
ClariFix Cryoablation Clinical Study
Source: ClinicalTrials.gov NCT02820597 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Device- and/or Procedure-related Serious Adverse Events — 0 participants
Summary
This is a single-arm pilot study designed to evaluate the feasibility of cryoablation in the nasal passageway, using the ClariFix device, to reduce the symptoms of chronic rhinitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device- and/or Procedure-related Serious Adverse Events |
— | — |
| PRIMARY Change in Rhinitis Symptom Severity (rTNSS) |
-1.9; -3.6; -3.3; -4.0; -4.5 | <0.001 sig |
| PRIMARY Change in Rhinitis Symptoms (VAS) |
-2.1; -3.8; -4.1; -2.9; -5.6 | <0.001 sig |
| SECONDARY Ease of Use |
14; 10; 3; 0 | — |
| SECONDARY Device- and/or Procedure-related Adverse Events |
1 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is >21 years of age
- Subject has had moderate to severe symptoms of rhinorrhea and/or nasal congestion for >3 months (rTNSS rating of 2 or 3)
- Subject has signed IRB-approved informed consent form
Exclusion Criteria
- Subject has clinically significant anatomic obstructions that limit access to the posterior nose including severe septal deviation, nasal polyps, and sinonasal tumor
- Subject has a septal perforation
- Subject has had prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose
- Subject has had prior head or neck irradiation
- Subject has active or chronic nasal or sinus infection
- Subject has active coagulation disorder or patient is receiving anti-coagulants which cannot be safely stopped for 2 weeks
- Subject has a history of dry nose symptoms
- Subject is pregnant or lactating
- Subject is participating in another clinical research study
- Subject has an allergy or intolerance to anesthetic agent
- Subject is an active smoker or has been a smoker within the last 6 months
- Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk
Data sourced from ClinicalTrials.gov (NCT02820597). 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. Informational only — not medical advice.