ClariFix Cryoablation Clinical Study

Clinical Evaluation of Cryotherapy in the Nasal Passageway Using the ClariFix Device

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.

Study Overview

• Status: Completed
• Conditions: Rhinitis
• Intervention / Treatment: Device: ClariFix device

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Cryoablation with the ClariFix device	Device: ClariFix device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device- and/or Procedure-related Serious Adverse Events	Number of participants with device- and/or procedure-related serious adverse events reported over the initial study follow-up period.	Baseline through 365 days post treatment
Change in Rhinitis Symptom Severity (rTNSS)	Change from baseline in participant-reported symptom severity based on the rTNSS (Reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. The rTNSS has a possible score range of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 12 hours.	Baseline through 365 days post treatment
Change in Rhinitis Symptoms (VAS)	Change from baseline in rhinitis symptoms measured on a participant-reported visual analog scale (VAS). Symptoms of rhinorrhea, nasal breathing, facial pain/pressure, and sense of smell were rated from 0 (no symptoms) to 10 (severe/extremely bothersome symptoms) assessed over the 12 hours preceding the visit. An average of the 4 individual scores was used as the total VAS score with a range of 0 to 10.	Baseline through 365 days post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of Use	Physician evaluation of ClariFix ease of use. After each participant's treatment, the physician was asked to rate the ClariFix on ease of use. Options were easy, moderately easy, moderately difficult, or difficult.	Immediately post treatment
Device- and/or Procedure-related Adverse Events	All adverse events evaluated as possibly, probably, or definitely related to the ClariFix device and/or procedure.	Baseline through 90 days post treatment

Collaborators and Investigators

• Sponsor: Arrinex, Inc.
• Investigators: Principal Investigator: Jacob Johnson, MD, San Francisco Otolaryngology Medical Group

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2015
• Primary Completion (Actual): February 5, 2016
• Study Completion (Actual): July 20, 2016

Study Registration Dates

• First Submitted: June 29, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (Estimate): July 1, 2016

Study Record Updates

• Last Update Posted (Actual): October 21, 2019
• Last Update Submitted That Met QC Criteria: October 17, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Rhinitis
• Other Study ID Numbers: A2014-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No