ClariFix
DeviceThe ClariFix™ device (K162608) is an FDA 510(k) cleared Class II cryosurgical tool indicated for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.
NCT Number: NCT03791489
Feasibility of treatment at multiple sites with the ClariFix cryoablation device for treatment of chronic rhinitis
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Notify Me18 year and older
All sexes
Interventional
Not applicable
San Francisco Otolaryngology Medical Group, San Francisco, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The ClariFix™ device (K162608) is an FDA 510(k) cleared Class II cryosurgical tool indicated for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.
Time frame: Study duration (90-days)
The outcome measure is the number of participants experiencing 1 or more SAEs/SADEs.
Time frame: Day of treatment during procedure and for up to 1 hour post procedure
Tolerability of treatment as provided by the participant by verbal report of pain/discomfort during treatment and post treatment using an 11-point scale indicating pain intensity from 0 (no pain) to 10 (worst pain).
Time frame: 30 and 90 days after treatment
The rTNSS is a validated patient-reported outcome measure consisting of 4 symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. Each item is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). The total rTNSS is the sum of the 4 symptom scores and has a possible range of 0 to 12 points. The change from baseline is calculated as the follow-up value minus the baseline value. Negative values indicate improved symptoms.
Time frame: 30 and 90 days after treatment
The NOSE survey is a patient-reported outcome measure consisting of 5 nasal symptoms: nasal congestion or stuffiness, nasal blockage or obstruction, trouble breathing through the nose, trouble sleeping, and unable to get enough air through the nose during exercise or exertion. Each symptom is scored using a 5-point scale of 0 (not a problem) to 4 (severe problem). The 5 symptom scores are summed and the total is multiplied by 5 to give a total score that ranges from 0 to 100, with higher scores indicating worse symptoms. The change from baseline is calculated as the follow-up value minus the baseline value. Negative values indicate improved symptoms.
Arrinex, Inc.
Industry
Feasibility Study of Multi-Treatment Posterior Nasal Nerve (PNN) Modulation for Treatment of Chronic Rhinitis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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