Trial Outcomes & Findings for ClariFix Cryoablation Clinical Study (NCT NCT02820597)

NCT ID: NCT02820597

Last Updated: 2019-10-21

Results Overview

Number of participants with device- and/or procedure-related serious adverse events reported over the initial study follow-up period.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: Baseline through 365 days post treatment
• Results posted on: 2019-10-21

Participant Flow

27 participants were enrolled and treated with bilateral cryotherapy of the nasal passage (54 treatments).

Participant milestones

Measure	Intervention Cryoablation with the ClariFix device
Overall Study STARTED	27
Overall Study 1-day Post Treatment	27
Overall Study 7-day Post Treatment	27
Overall Study 30-day Post Treatment	27
Overall Study 90-day Post Treatment	24
Overall Study 180-day Post Treatment	21
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Measure	Intervention Cryoablation with the ClariFix device
Overall Study Lost to Follow-up	12

Baseline Characteristics

ClariFix Cryoablation Clinical Study

Baseline characteristics by cohort

Measure	Intervention n=27 Participants Treatment with the ClariFix Device ClariFix Device
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	53.29 Years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline through 365 days post treatment

Population: A total of 27 subjects were enrolled and received bilateral cryosurgery with the ClariFix device (n=54 treatments).

Number of participants with device- and/or procedure-related serious adverse events reported over the initial study follow-up period.

Outcome measures

Measure	Intervention n=27 Participants Cryoablation with the ClariFix device
Device- and/or Procedure-related Serious Adverse Events	0 participants

PRIMARY outcome

Timeframe: Baseline through 365 days post treatment

Population: All participants with follow-up at the indicated visits.

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.

Outcome measures

Measure	Intervention n=27 Participants Cryoablation with the ClariFix device
Change in Rhinitis Symptom Severity (rTNSS) 7 Days post treatment	-1.9 score on a scale Standard Deviation 0.6
Change in Rhinitis Symptom Severity (rTNSS) 30 Days post treatment	-3.6 score on a scale Standard Deviation 0.6
Change in Rhinitis Symptom Severity (rTNSS) 90 Days post treatment	-3.3 score on a scale Standard Deviation 0.6
Change in Rhinitis Symptom Severity (rTNSS) 180 Days post treatment	-4.0 score on a scale Standard Deviation 0.5
Change in Rhinitis Symptom Severity (rTNSS) 365 Days post treatment	-4.5 score on a scale Standard Deviation 0.3

PRIMARY outcome

Timeframe: Baseline through 365 days post treatment

Population: All treated participants with follow-up at the indicated visits.

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.

Outcome measures

Measure	Intervention n=27 Participants Cryoablation with the ClariFix device
Change in Rhinitis Symptoms (VAS) 7 Days post treatment	-2.1 score on a scale Standard Deviation 0.5
Change in Rhinitis Symptoms (VAS) 30 Days post treatment	-3.8 score on a scale Standard Deviation 0.5
Change in Rhinitis Symptoms (VAS) 90 Days post treatment	-4.1 score on a scale Standard Deviation 0.6
Change in Rhinitis Symptoms (VAS) 180 Days post treatment	-2.9 score on a scale Standard Deviation 0.7
Change in Rhinitis Symptoms (VAS) 365 Days post treatment	-5.6 score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Immediately post treatment

Population: Physician evaluation of ease of use after each ClariFix procedure.

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.

Outcome measures

Measure	Intervention n=27 Procedures Cryoablation with the ClariFix device
Ease of Use Difficult	0 Procedures
Ease of Use Easy	14 Procedures
Ease of Use Moderately easy	10 Procedures
Ease of Use Moderately difficult	3 Procedures

SECONDARY outcome

Timeframe: Baseline through 90 days post treatment

Population: All treated participants.

All adverse events evaluated as possibly, probably, or definitely related to the ClariFix device and/or procedure.

Outcome measures

Measure	Intervention n=27 Participants Cryoablation with the ClariFix device
Device- and/or Procedure-related Adverse Events	1 Participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention n=27 participants at risk Treatment with the ClariFix Device ClariFix Device
General disorders Ear blockage	44.4% 12/27 • Number of events 12 • 1 Year Adverse events were systematically reported at each follow-up visit.
General disorders Nasal Dryness	25.9% 7/27 • Number of events 7 • 1 Year Adverse events were systematically reported at each follow-up visit.
General disorders Epitaxsis	3.7% 1/27 • Number of events 1 • 1 Year Adverse events were systematically reported at each follow-up visit.

Additional Information

Principal Clinical Research & Publications Manager

Stryker ENT

Phone: 763-463-1598

Email: ellen.omalley@stryker.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place