ClariFix Cryoablation Clinical Study

Arrinex

Status: Completed

Conditions: Rhinitis

Treatments: Device: ClariFix device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02820597

A2014-02

Details and patient eligibility

About

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.

Full description

This is a small, prospective, multicenter, single-arm, self-controlled interventional feasibility study to evaluation cryoablation in the nasal passage as a treatment for chronic rhinitis. The ClariFix device is FDA-cleared device with the intended use for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.

Enrollment: 27 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is >21 years of age
2. Subject has had moderate to severe symptoms of rhinorrhea and/or nasal congestion for >3 months (rTNSS rating of 2 or 3)
3. Subject has signed IRB-approved informed consent form

Exclusion criteria

1. Subject has clinically significant anatomic obstructions that limit access to the posterior nose including severe septal deviation, nasal polyps, and sinonasal tumor
2. Subject has a septal perforation
3. Subject has had prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose
4. Subject has had prior head or neck irradiation
5. Subject has active or chronic nasal or sinus infection
6. Subject has active coagulation disorder or patient is receiving anti-coagulants which cannot be safely stopped for 2 weeks
7. Subject has a history of dry nose symptoms
8. Subject is pregnant or lactating
9. Subject is participating in another clinical research study
10. Subject has an allergy or intolerance to anesthetic agent
11. Subject is an active smoker or has been a smoker within the last 6 months
12. Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

27 participants in 1 patient group

Intervention

Experimental group

Description:

Cryoablation with the ClariFix device

Treatment:

Device: ClariFix device