Registry of Subject Treated With ClariFix | NCT03739216 | Trialant

Registry of Subject Treated With ClariFix | NCT03739216 | Trialant

Arms/Interventions Module

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ClariFix	Device	The ClariFix device is a handheld cryosurgical device which provides focal, controlled freezing to the target tissue.	Open label

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in nasal symptom severity	Effectiveness will be assessed by the change from baseline in nasal symptoms using the TNSS (Total Nasal Symptom Score). The TNSS is a patient-reported assessment of 4 symptom scores for rhinorrhea (runny nose), nasal congestion, nasal itching, and sneezing. Each symptom is rated on a scale of 0 (none) to 3 (severe). The symptom scores are summed to give a total TNSS score that can range from 0 to 12.	Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months post treatment

Secondary Outcomes

Measure	Description	Time Frame
Patient-assessed improvement in nasal symptoms	Percentage of participants reporting their change from baseline as minimally improved, much improved, or very much improved using the Patient Global Impression of Change (PGIC) assessment. The PGIC has patients evaluate their improvement over baseline on a scale from 1 (very much improved) to 7 (very much worse).	Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months post treatment

Contacts/Locations Module