Study of the ClariFix Cryoablation Device in Patients with Chronic Rhinitis - New Zealand

Recruiting

• Conditions: Chronic rhinitis; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12614000468628
• Lead Sponsor: Arrinex, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

a)Subject is >18 years of age
b)Subject has had moderate to severe symptoms of rhinorrhea and nasal congestion for >6 months (rTNSS rating of 2 or 3 for rhinorrhea and congestion)
c)Subject has signed EC-approved informed consent form

Exclusion Criteria

a)Subject has clinically significant anatomic obstructions that limit access to the posterior nose including severe septal deviation, nasal polyps, and sinonasal tumor
b)Subject has a septal perforation
c)Subject has had prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose
d)Subject has had prior head or neck irradiation
e)Subject has active or chronic nasal or sinus infection
f)Subject has active coagulation disorder or patient is receiving anti-coagulants which cannot be safely stopped for 2 weeks
g)Subject has a history of dry eye or dry nose symptoms
h)Subject is pregnant
i)Subject is participating in another clinical research study
j)Subject has an allergy or intolerance to anesthetic agent
k)Subject is an active smoker or has been a smoker within the last 6 months
l)Any physical condition that in the investigator’s opinion would prevent adequate study participation or pose increased risk

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of device- and procedure-related serious adverse events (SAEs) Adverse events will be assessed by patient interviews and physical examination and rhinoscopy at follow up visits. Examples of possible adverse events include infection, bleeding, pain, swelling, scarring, and sensory alterations.[Within 90 days post-treatment];Efficacy endpoint: Change in nasal symptoms from baseline, using the four-symptom rTNSS (reflective Total Nasal Symptom Score)[90 days post-treatment]

Secondary Outcome Measures

Name	Time	Method
Impact on quality of life assessed by the Rhinoconjunctivitis Quality of Life<br>Questionnaire (RQLQ)[90 days post-treatment]