ClariFix Cryoablation Clinical Study

Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820597
• Other study ID #: A2014-02
• Status: Completed
• Phase: N/A
• Start date: June 15, 2015
• Est. completion date: July 20, 2016

Study information

• Verified date: October 2019
• Source: Arrinex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 20, 2016
• Est. primary completion date: February 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rhinitis

Intervention

Device:
• ClariFix device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Arrinex, Inc.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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