Back to resultsMulti-Treatment PNN Modulation for Chronic Rhinitis
Primary Purpose
Chronic Rhinitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ClariFix
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinitis
Eligibility Criteria
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.
Sites / Locations
- San Francisco Otolaryngology Medical Group
- Bethlehem ENT
- Tracy Byerly, MD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active Treatment
Arm Description
Cryotherapy of the posterior nasal nerve using the ClariFix device
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03791489
Brief Title
Multi-Treatment PNN Modulation for Chronic Rhinitis
Official Title
Feasibility Study of Multi-Treatment Posterior Nasal Nerve (PNN) Modulation for Treatment of Chronic Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
July 18, 2019 (Actual)
Study Completion Date
July 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arrinex, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Feasibility of treatment at multiple sites with the ClariFix cryoablation device for treatment of chronic rhinitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, non-randomized, feasibility study of multi-treatment locations
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Treatment
Arm Type
Experimental
Arm Description
Cryotherapy of the posterior nasal nerve using the ClariFix device
Intervention Type
Device
Intervention Name(s)
ClariFix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Procedure-related Serious Adverse Events (SAEs) and/or Serious Adverse Device Effects (SADE)
Description
The outcome measure is the number of participants experiencing 1 or more SAEs/SADEs.
Time Frame
Study duration (90-days)
Secondary Outcome Measure Information:
Title
Pain Scores
Description
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).
Time Frame
Day of treatment during procedure and for up to 1 hour post procedure
Title
Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)
Description
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.
Time Frame
30 and 90 days after treatment
Title
Change From Baseline in the Overall Nasal Obstruction Symptom Evaluation (NOSE) Score
Description
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.
Time Frame
30 and 90 days after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Yen, MD
Organizational Affiliation
Specialty Physician Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco Otolaryngology Medical Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94108
Country
United States
Facility Name
Bethlehem ENT
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Tracy Byerly, MD
City
Fredericksburg
State/Province
Texas
ZIP/Postal Code
78624
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multi-Treatment PNN Modulation for Chronic Rhinitis
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