ClariFix Cryoablation Clinical Study

NCT ID: NCT02820597

Last Updated: 2019-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-15
• Study Completion Date: 2016-07-20

Brief Summary

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.

Detailed 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.

Conditions

Rhinitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Cryoablation with the ClariFix device

Group Type: EXPERIMENTAL

ClariFix device

Intervention Type: DEVICE

Interventions

ClariFix device

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arrinex, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacob Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

San Francisco Otolaryngology Medical Group

References

Hwang PH, Lin B, Weiss R, Atkins J, Johnson J. Cryosurgical posterior nasal tissue ablation for the treatment of rhinitis. Int Forum Allergy Rhinol. 2017 Oct;7(10):952-956. doi: 10.1002/alr.21991. Epub 2017 Aug 11.

Reference Type: RESULT

PMID: 28799727 (View on PubMed)

Other Identifiers

A2014-02

Identifier Type: -

Identifier Source: org_study_id