RecruitingACTRN12614000468628

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

Safety and Efficacy Study of the ClariFix Cryoablation Device in Patients with Chronic Rhinitis


Sponsor

Arrinex, Inc.

Enrollment

30 participants

Start Date

Nov 1, 2016

Study Type

Interventional

Conditions

Summary

Prior studies have shown that cryoablation in the nose improves nasal symptoms in patients with chronic rhinitis. This study is a prospective, non-randomized clinical study to assess the safety and effectiveness of the ClariFix Cryoablation Device when used to ablate unwanted tissue in the nose of patients with chronic rhinitis.


Eligibility

Sex: Both males and femalesMin Age: 19 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a device called the ClariFix Cryoablation Device, which uses cold temperatures to treat the nerve tissue in the back of the nose that causes chronic rhinitis (a long-term runny, blocked nose). This study is being conducted in New Zealand to evaluate how safe and effective this device is for people with moderate to severe nasal symptoms. You may be eligible if: - You are over 18 years of age - You have had moderate to severe runny nose and nasal congestion for more than 6 months - You have signed an informed consent form You may NOT be eligible if: - You have significant blockages in the nose such as severe nasal polyps or a tumour - You have a hole in the wall separating the nostrils (septal perforation) - You have had major sinus or nasal surgery that changed the anatomy of the back of your nose - You have had previous radiation treatment to the head or neck - You have an active nasal or sinus infection - You have a blood clotting disorder or are on blood thinners that cannot be safely stopped - You have dry eye or dry nose symptoms - You are pregnant - You are currently in another clinical study - You are an active smoker or have smoked in the past 6 months Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

The intervention consists of cryoablation in the nasal passageway using a new cryosurgical device called the ClariFix Device. The ClariFix Device circulates liquid nitrous oxide through a closed-tip c

The intervention consists of cryoablation in the nasal passageway using a new cryosurgical device called the ClariFix Device. The ClariFix Device circulates liquid nitrous oxide through a closed-tip cryoprobe, where it is allowed to expand through a fine annular space. The transformation of the liquid into gas extracts heat from the surrounding areas by the Joule-Thompson effect. Either one or two treatments are delivered in each nasal cavity under endoscopic visualization, for a total of two to four treatments per patient. The treatment is delivered under local anesthesia. The total procedure time is approximately 30 minutes. The study procedure is performed only once per patient; there are no repeat procedures.


Locations(1)

New Zealand

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12614000468628


Related Trials