ClariFix Cryoablation Clinical Study

NCT02820597 | Completed Results FDA Device

• 1 other identifier: A2014-02
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rhinitis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Ease of Use

  Immediately post treatment

• Device- and/or Procedure-related Adverse Events

  Baseline through 90 days post treatment

Study Arms (1)

Intervention

EXPERIMENTAL

Cryoablation with the ClariFix device

Device: ClariFix device

Interventions

ClariFix device DEVICE

Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Arrinex, Inc.: lead

Related 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.

  PMID: 28799727 RESULT

MeSH Terms

Conditions

Rhinitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Limitations and Caveats

This is a feasibility study based on a small population of participants.

Results Point of Contact

• Title: Principal Clinical Research & Publications Manager
• Organization: Stryker ENT

ellen.omalley@stryker.com

763-463-1598

Study Officials

• Jacob Johnson, MD

  San Francisco Otolaryngology Medical Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 1, 2016
• Study Start: June 15, 2015
• Primary Completion: February 5, 2016
• Study Completion: July 20, 2016
• Last Updated: October 21, 2019
• Results First Posted: October 21, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share