Trial Outcomes & Findings for Evaluation of the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis (NCT NCT03181594)
NCT ID: NCT03181594
Last Updated: 2021-03-17
Results Overview
Effectiveness will be assessed by the mean change in nasal symptoms using the 4-symptom rTNSS (reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual patient-rated symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, and 3=Severe. The rTNSS has a possible score of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 24 hours. A change of 1 or more is considered the minimum clinically important difference.
COMPLETED
NA
100 participants
90 days post treatment
2021-03-17
Participant Flow
Participant milestones
| Measure |
Treatment With the ClariFix Device
Bilateral ablation of nasal tissue for treatment of chronic rhinitis
ClariFix Device: Cryoablation in the nasal passageway using the ClariFix Device
|
|---|---|
|
Initial Study Protocol (12-month FU)
STARTED
|
100
|
|
Initial Study Protocol (12-month FU)
30-day Follow-up
|
99
|
|
Initial Study Protocol (12-month FU)
90-day Follow-up
|
98
|
|
Initial Study Protocol (12-month FU)
6-month Follow-up
|
98
|
|
Initial Study Protocol (12-month FU)
9-month Follow-up
|
95
|
|
Initial Study Protocol (12-month FU)
12-month Follow-up
|
91
|
|
Initial Study Protocol (12-month FU)
COMPLETED
|
91
|
|
Initial Study Protocol (12-month FU)
NOT COMPLETED
|
9
|
|
Long-term Extension (15-24 Month FU)
STARTED
|
62
|
|
Long-term Extension (15-24 Month FU)
15-month Follow-up
|
56
|
|
Long-term Extension (15-24 Month FU)
18-month Follow-up
|
57
|
|
Long-term Extension (15-24 Month FU)
21-month Follow-up
|
55
|
|
Long-term Extension (15-24 Month FU)
24-month Follow-up
|
57
|
|
Long-term Extension (15-24 Month FU)
COMPLETED
|
57
|
|
Long-term Extension (15-24 Month FU)
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Treatment With the ClariFix Device
Bilateral ablation of nasal tissue for treatment of chronic rhinitis
ClariFix Device: Cryoablation in the nasal passageway using the ClariFix Device
|
|---|---|
|
Initial Study Protocol (12-month FU)
Lost to Follow-up
|
4
|
|
Initial Study Protocol (12-month FU)
Withdrawal by Subject
|
3
|
|
Initial Study Protocol (12-month FU)
Physician Decision
|
1
|
|
Initial Study Protocol (12-month FU)
Death
|
1
|
|
Long-term Extension (15-24 Month FU)
Lost to Follow-up
|
3
|
|
Long-term Extension (15-24 Month FU)
Death
|
2
|
Baseline Characteristics
Evaluation of the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis
Baseline characteristics by cohort
| Measure |
Treatment With the ClariFix Device
n=100 Participants
Bilateral ablation of nasal tissue for treatment of chronic rhinitis
ClariFix Device: Cryoablation in the nasal passageway using the ClariFix Device
|
|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
90 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
|
Rhinitis subtype
Allergic
|
30 Participants
n=5 Participants
|
|
Rhinitis subtype
Non-allergic
|
70 Participants
n=5 Participants
|
|
Baseline rTNSS
|
6.14 units on a scale
STANDARD_DEVIATION 1.87 • n=5 Participants
|
PRIMARY outcome
Timeframe: 90 days post treatmentPopulation: All treated participants with 90-day follow-up.
Effectiveness will be assessed by the mean change in nasal symptoms using the 4-symptom rTNSS (reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual patient-rated symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, and 3=Severe. The rTNSS has a possible score of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 24 hours. A change of 1 or more is considered the minimum clinically important difference.
Outcome measures
| Measure |
Treatment With the ClariFix Device
n=98 Participants
Bilateral ablation of nasal tissue for treatment of chronic rhinitis
ClariFix Device: Cryoablation in the nasal passageway using the ClariFix Device
|
|---|---|
|
Change From Baseline in Symptom Severity
|
-3.1 score on a scale
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: 90 days post treatmentPopulation: All treated participants.
Safety will be evaluated based on the frequency of device- and/or procedure-related serious adverse events
Outcome measures
| Measure |
Treatment With the ClariFix Device
n=100 Participants
Bilateral ablation of nasal tissue for treatment of chronic rhinitis
ClariFix Device: Cryoablation in the nasal passageway using the ClariFix Device
|
|---|---|
|
Device- and/or Procedure-related Serious Adverse Events
|
1 events
|
SECONDARY outcome
Timeframe: 90 days post treatmentPopulation: All treated participants with 90-day follow-up.
The RQLQ is a validated quality of life questionnaire that evaluates functional problems associated with rhinitis. The questionnaire assess 7 domains: activities, sleep, nose symptoms, eye symptoms, non nose/eye symptoms, practical problems, and emotional function. Each question is scores on a 7-point scale (0=not impaired at all, 6=severely impaired). A domain and total scores are based on the mean of all answered items in that domain resulting in domain or total scores ranging from 0 to 6. An average change on 0.5 or more is considered a minimal clinically important difference.
Outcome measures
| Measure |
Treatment With the ClariFix Device
n=98 Participants
Bilateral ablation of nasal tissue for treatment of chronic rhinitis
ClariFix Device: Cryoablation in the nasal passageway using the ClariFix Device
|
|---|---|
|
Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
|
-1.5 score on a scale
Standard Deviation 1.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1, 3, 6, 9, 12, 15, 18, 21, and 24 months post procedurePopulation: All participants with rTNSS scores.
Median change in nasal symptoms using the 4-symptom rTNSS (reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual patient-rated symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, and 3=Severe. The rTNSS has a possible score of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 24 hours. A change of 1 point or more is considered the minimum clinically important difference.
Outcome measures
| Measure |
Treatment With the ClariFix Device
n=99 Participants
Bilateral ablation of nasal tissue for treatment of chronic rhinitis
ClariFix Device: Cryoablation in the nasal passageway using the ClariFix Device
|
|---|---|
|
Change From Baseline in Symptom Severity
1-month
|
-3.0 score on a scale
Interval -4.0 to -2.0
|
|
Change From Baseline in Symptom Severity
3-month
|
-3.0 score on a scale
Interval -4.0 to -1.0
|
|
Change From Baseline in Symptom Severity
6-month
|
-3.0 score on a scale
Interval -4.0 to -2.0
|
|
Change From Baseline in Symptom Severity
9-month
|
-3.0 score on a scale
Interval -4.0 to -2.0
|
|
Change From Baseline in Symptom Severity
12-month
|
-3.0 score on a scale
Interval -4.0 to -1.0
|
|
Change From Baseline in Symptom Severity
15-month
|
-4.0 score on a scale
Interval -5.0 to -3.0
|
|
Change From Baseline in Symptom Severity
18-month
|
-3.0 score on a scale
Interval -5.0 to -2.0
|
|
Change From Baseline in Symptom Severity
21-month
|
-4.0 score on a scale
Interval -5.0 to -2.0
|
|
Change From Baseline in Symptom Severity
24-month
|
-4.0 score on a scale
Interval -5.0 to -2.0
|
Adverse Events
Treatment With the ClariFix Device
Serious adverse events
| Measure |
Treatment With the ClariFix Device
n=100 participants at risk
Bilateral ablation of nasal tissue for treatment of chronic rhinitis
ClariFix Device: Cryoablation in the nasal passageway using the ClariFix Device
|
|---|---|
|
Infections and infestations
Foot infection
|
1.0%
1/100 • Number of events 1 • All adverse events from procedure through 9 months post treatment.
|
|
Gastrointestinal disorders
Colectomy
|
1.0%
1/100 • Number of events 1 • All adverse events from procedure through 9 months post treatment.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliac joint dysfunction
|
1.0%
1/100 • Number of events 1 • All adverse events from procedure through 9 months post treatment.
|
|
Surgical and medical procedures
Retained pledget/epistaxis
|
1.0%
1/100 • Number of events 2 • All adverse events from procedure through 9 months post treatment.
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/100 • Number of events 1 • All adverse events from procedure through 9 months post treatment.
|
|
Vascular disorders
Carotid stenosis
|
1.0%
1/100 • Number of events 1 • All adverse events from procedure through 9 months post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
4.0%
4/100 • Number of events 4 • All adverse events from procedure through 9 months post treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
1.0%
1/100 • Number of events 1 • All adverse events from procedure through 9 months post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
1.0%
1/100 • Number of events 2 • All adverse events from procedure through 9 months post treatment.
|
Other adverse events
Adverse event data not reported
Additional Information
Principal Clinical Research & Publications Manager
Stryker ENT
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60