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History of Changes for Study: NCT02820597
ClariFix Cryoablation Clinical Study
Latest version (submitted October 17, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 30, 2016 None (earliest Version on record)
2 September 9, 2016 Arms and Interventions, Outcome Measures, Study Status, Study Identification and Study Description
3 January 23, 2017 Recruitment Status, Study Status, Study Design
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Results Submission Events
4 October 17, 2019 Study Status, Outcome Measures, Oversight, Study Description, Results, References, Contacts/Locations and Arms and Interventions
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Study NCT02820597
Submitted Date:  October 17, 2019 (v4)

Study Identification
Unique Protocol ID: A2014-02
Brief Title: ClariFix Cryoablation Clinical Study
Official Title: Clinical Evaluation of Cryotherapy in the Nasal Passageway Using the ClariFix Device
Secondary IDs:
Study Status
Record Verification: October 2019
Overall Status: Completed
Study Start: June 15, 2015
Primary Completion: February 5, 2016 [Actual]
Study Completion: July 20, 2016 [Actual]
First Submitted: June 29, 2016
First Submitted that
Met QC Criteria:
June 30, 2016
First Posted: July 1, 2016 [Estimate]
Results First Submitted: December 10, 2018
Results First Submitted that
Met QC Criteria:
October 17, 2019
Results First Posted: October 21, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
October 17, 2019
Last Update Posted: October 21, 2019 [Actual]
Sponsor/Collaborators
Sponsor: Arrinex, Inc.
Responsible Party: Sponsor
Collaborators:
Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Product Exported from U.S.: No
Data Monitoring: No
Study Description
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.
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.
Conditions
Conditions: Rhinitis
Keywords:
Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 27 [Actual]
Arms and Interventions
Arms Assigned Interventions
Experimental: Intervention
Cryoablation with the ClariFix device
Device: ClariFix device
Outcome Measures
Eligibility
Minimum Age: 21 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Contacts/Locations
Study Officials: Jacob Johnson, MD
Principal Investigator
San Francisco Otolaryngology Medical Group
Locations:
IPDSharing
Plan to Share IPD: No
References
Citations: [Study Results] 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. PubMed 28799727
Links:
Available IPD/Information:
Study Results
Participant Flow
Recruitment Details 27 participants were enrolled and treated with bilateral cryotherapy of the nasal passage (54 treatments).
Reporting Groups
Description
Intervention Cryoablation with the ClariFix device
Overall Study
  Intervention
Started 27
1-day Post Treatment 27
7-day Post Treatment 27
30-day Post Treatment 27
90-day Post Treatment 24[1]
180-day Post Treatment 21[2]
Completed 15[3]
Not Completed 12
Lost to Follow-up 12
[1]2 participants missed the 90-day visit, 1 participant was lost to follow-up.
[2]3 participants missed the 180-day visit, 3 participants were lost to follow-up.
[3]12 participants were lost to follow-up.
Baseline Characteristics
Reporting Groups
Description
Intervention

Treatment with the ClariFix Device

ClariFix Device

Baseline Measures
    Intervention
Overall Number of Participants 27
Age, Categorical
Measure type: Count of Participants
Unit of measure: Participants
Number Analyzed27 Participants
<=18 years0 0%
Between 18 and 65 years20 74.07%
>=65 years7 25.93%
Age, Continuous
Mean (Full Range)
Unit of measure: Years
Number Analyzed27 Participants
53.29(27 to 87)
Sex: Female, Male
Measure type: Count of Participants
Unit of measure: Participants
Number Analyzed27 Participants
Female17 62.96%
Male10 37.04%
Region of Enrollment
Measure type: Number
Unit of measure: participants
Number Analyzed27 Participants
United States
27 100%
Outcome Measures
1. Primary Outcome Measure:
Measure Title Device- and/or Procedure-related Serious Adverse Events
Measure Description Number of participants with device- and/or procedure-related serious adverse events reported over the initial study follow-up period.
Time Frame Baseline through 365 days post treatment
Analysis Population Description
A total of 27 subjects were enrolled and received bilateral cryosurgery with the ClariFix device (n=54 treatments).
Reporting Groups
Description
Intervention Cryoablation with the ClariFix device
Measured Values
  Intervention
Overall Number of Participants Analyzed 27
Device- and/or Procedure-related Serious Adverse Events
Measure Type: Number
Unit of Measure: participants
0
2. Primary Outcome Measure:
Measure Title Change in Rhinitis Symptom Severity (rTNSS)
Measure Description 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.
Time Frame Baseline through 365 days post treatment
Analysis Population Description
All participants with follow-up at the indicated visits.
Reporting Groups
Description
Intervention Cryoablation with the ClariFix device
Measured Values
  Intervention
Overall Number of Participants Analyzed 27
Change in Rhinitis Symptom Severity (rTNSS)
Measure Type: Mean (Standard Deviation)
Unit of Measure: score on a scale
7 Days post treatment -1.9 (0.6)
30 Days post treatment -3.6 (0.6)
90 Days post treatment -3.3 (0.6)
180 Days post treatment -4.0 (0.5)
365 Days post treatment -4.5 (0.3)
Statistical Analysis 1 for Change in Rhinitis Symptom Severity (rTNSS)
Statistical Analysis OverviewComparison GroupsIntervention
CommentsNull hypothesis is that the within-participant change from baseline in rTNSS is 0.
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value<0.001
Comments[Not specified]
Methodt-test, 2 sided
CommentsPaired t-tests on the mean change from baseline. No adjustments were made for multiple comparisons.
3. Primary Outcome Measure:
Measure Title Change in Rhinitis Symptoms (VAS)
Measure Description 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.
Time Frame Baseline through 365 days post treatment
Analysis Population Description
All treated participants with follow-up at the indicated visits.
Reporting Groups
Description
Intervention Cryoablation with the ClariFix device
Measured Values
  Intervention
Overall Number of Participants Analyzed 27
Change in Rhinitis Symptoms (VAS)
Measure Type: Mean (Standard Deviation)
Unit of Measure: score on a scale
7 Days post treatment -2.1 (0.5)
30 Days post treatment -3.8 (0.5)
90 Days post treatment -4.1 (0.6)
180 Days post treatment -2.9 (0.7)
365 Days post treatment -5.6 (1.1)
Statistical Analysis 1 for Change in Rhinitis Symptoms (VAS)
Statistical Analysis OverviewComparison GroupsIntervention
CommentsNull hypothesis is that the within-participant change from baseline in rhinitis symptoms VAS is 0.
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value<0.001
CommentsPaired t-tests on the mean change from baseline. No adjustments were made for multiple comparisons.
Methodt-test, 2 sided
Comments[Not specified]
4. Secondary Outcome Measure:
Measure Title Ease of Use
Measure Description 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.
Time Frame Immediately post treatment
Analysis Population Description
Physician evaluation of ease of use after each ClariFix procedure.
Reporting Groups
Description
Intervention Cryoablation with the ClariFix device
Measured Values
    Intervention
Overall Number of Participants Analyzed 27
Overall Number of Units Analyzed
Type of Units Analyzed: Procedures
27
Ease of Use
Measure Type: Count of Units
Unit of Measure: Procedures
Easy 14
Moderately easy 10
Moderately difficult 3
Difficult 0
5. Secondary Outcome Measure:
Measure Title Device- and/or Procedure-related Adverse Events
Measure Description All adverse events evaluated as possibly, probably, or definitely related to the ClariFix device and/or procedure.
Time Frame Baseline through 90 days post treatment
Analysis Population Description
All treated participants.
Reporting Groups
Description
Intervention Cryoablation with the ClariFix device
Measured Values
  Intervention
Overall Number of Participants Analyzed 27
Device- and/or Procedure-related Adverse Events
Measure Type: Count of Participants
Unit of Measure: Participants
1
Reported Adverse Events
Time Frame 1 Year
Adverse Event Reporting Description Adverse events were systematically reported at each follow-up visit.
Reporting Groups
Description
Intervention

Treatment with the ClariFix Device

ClariFix Device

All-Cause Mortality
  Intervention
 Affected/At Risk (%)# Events
Total 0/27 (0%)
Serious Adverse Events
  Intervention
 Affected/At Risk (%)# Events
Total 0/27 (0%)
Other Adverse Events
Frequency Threshold Above Which Other Adverse Events are Reported: 0%
  Intervention
 Affected/At Risk (%)# Events
Total 19/27 (70.37%)
General disorders
Ear blockage 12/27 (44.44%)12
Epitaxsis [1] 1/27 (3.7%)1
Nasal Dryness 7/27 (25.93%)7
Indicates events were collected by systematic assessment.
[1]Moderate nosebleed
Limitations and Caveats
This is a feasibility study based on a small population of participants.
More Information
Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact:
Name/Official Title: Principal Clinical Research & Publications Manager
Organization: Stryker ENT
Phone: 763-463-1598
Email: ellen.omalley@stryker.com

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