Multi-Treatment PNN Modulation for Chronic Rhinitis

Feasibility Study of Multi-Treatment Posterior Nasal Nerve (PNN) Modulation for Treatment of Chronic Rhinitis

Feasibility of treatment at multiple sites with the ClariFix cryoablation device for treatment of chronic rhinitis

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94108
      • San Francisco Otolaryngology Medical Group
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Bethlehem ENT
  • Texas
    • Fredericksburg, Texas, United States, 78624
      • Tracy Byerly, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Presence of moderate to severe rhinorrhea symptoms and mild to severe nasal congestion symptoms for >3 months.
• Documented allergy test within the last 10 years that defines whether or not subject has allergies to perennial and seasonal allergens, or is willing to have one performed prior to study exit.
• Able to provide informed consent and willing to complete study activities and visits per protocol.

Exclusion Criteria:

• Clinically significant anatomic obstructions that limit access to the posterior nose.
• Prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose.
• Moderate to severe ocular symptoms as determined.
• History of epistaxis in the past 3 months.
• History of rhinitis medicamentosa.
• Prior head or neck irradiation.
• Active or chronic nasal or sinus infection.
• Pregnant.
• Allergy or intolerance to anesthetic agent.
• Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or, open and/or infected wounds at or near the target tissue.
• Currently participating in another clinical research study.
• 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: Active Treatment; Cryotherapy of the posterior nasal nerve using the ClariFix device	Device: ClariFix; The ClariFix™ device (K162608) is an FDA 510(k) cleared Class II cryosurgical tool indicated for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Procedure-related Serious Adverse Events (SAEs) and/or Serious Adverse Device Effects (SADE)	The outcome measure is the number of participants experiencing 1 or more SAEs/SADEs.	Study duration (90-days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores	Tolerability of treatment as provided by the participant by verbal report of pain/discomfort during treatment and post treatment using an 11-point scale indicating pain intensity from 0 (no pain) to 10 (worst pain).	Day of treatment during procedure and for up to 1 hour post procedure
Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)	The rTNSS is a validated patient-reported outcome measure consisting of 4 symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. Each item is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). The total rTNSS is the sum of the 4 symptom scores and has a possible range of 0 to 12 points. The change from baseline is calculated as the follow-up value minus the baseline value. Negative values indicate improved symptoms.	30 and 90 days after treatment
Change From Baseline in the Overall Nasal Obstruction Symptom Evaluation (NOSE) Score	The NOSE survey is a patient-reported outcome measure consisting of 5 nasal symptoms: nasal congestion or stuffiness, nasal blockage or obstruction, trouble breathing through the nose, trouble sleeping, and unable to get enough air through the nose during exercise or exertion. Each symptom is scored using a 5-point scale of 0 (not a problem) to 4 (severe problem). The 5 symptom scores are summed and the total is multiplied by 5 to give a total score that ranges from 0 to 100, with higher scores indicating worse symptoms. The change from baseline is calculated as the follow-up value minus the baseline value. Negative values indicate improved symptoms.	30 and 90 days after treatment

Collaborators and Investigators

• Sponsor: Arrinex, Inc.
• Investigators: Principal Investigator: David Yen, MD, Specialty Physician Associates

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): July 18, 2019
• Study Completion (Actual): July 18, 2019

Study Registration Dates

• First Submitted: December 31, 2018
• First Submitted That Met QC Criteria: December 31, 2018
• First Posted (Actual): January 2, 2019

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: July 1, 2020

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: CT-0005

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