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Trial Outcomes & Findings for ClariFix Rhinitis RCT (NCT NCT04154605)

NCT ID: NCT04154605

Last Updated: 2025-03-26

Results Overview

Responders are defined as participants with a 30% or greater reduction in reflective Total Nasal Symptom Score (rTNSS) relative to baseline. The active treatment will be compared with the sham treatment. The reflective Total Nasal Symptom Score (rTNSS) is a validated PRO consisting of 4 nasal symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing that are assessed over the previous 2-week period. Each symptom is rated on a scale of 0 (no symptoms) to 3 (severe symptoms) and the scores are summed to provide a total rTNSS with a possible range of 0 to 12.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

133 participants

Primary outcome timeframe

90-days post treatment

Results posted on

2025-03-26

Participant Flow

Participant milestones

Participant milestones
Measure
ClariFix
Cryotherapy of the nasal passages with the ClariFix device. ClariFix cryotherapy: Bilateral freeze ablation of nasal tissue using the ClariFix device.
Sham
Sham cryotherapy of the nasal passages with the ClariFix device Sham ClariFix cryotherapy: Bilateral sham ablation procedure using the ClariFix device.
Overall Study
STARTED
68
65
Overall Study
COMPLETED
65
63
Overall Study
NOT COMPLETED
3
2

Reasons for withdrawal

Reasons for withdrawal
Measure
ClariFix
Cryotherapy of the nasal passages with the ClariFix device. ClariFix cryotherapy: Bilateral freeze ablation of nasal tissue using the ClariFix device.
Sham
Sham cryotherapy of the nasal passages with the ClariFix device Sham ClariFix cryotherapy: Bilateral sham ablation procedure using the ClariFix device.
Overall Study
Procedure Canceled
1
1
Overall Study
Missed follow up
1
1
Overall Study
Withdrawal by Subject
1
0

Baseline Characteristics

ClariFix Rhinitis RCT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ClariFix
n=68 Participants
Cryotherapy of the nasal passages with the ClariFix device. ClariFix cryotherapy: Bilateral freeze ablation of nasal tissue using the ClariFix device.
Sham
n=65 Participants
Sham cryotherapy of the nasal passages with the ClariFix device Sham ClariFix cryotherapy: Bilateral sham ablation procedure using the ClariFix device.
Total
n=133 Participants
Total of all reporting groups
Age, Continuous
52.3 years
STANDARD_DEVIATION 15.8 • n=5 Participants
58.3 years
STANDARD_DEVIATION 16.4 • n=7 Participants
55.2 years
STANDARD_DEVIATION 16.3 • n=5 Participants
Sex: Female, Male
Female
45 Participants
n=5 Participants
32 Participants
n=7 Participants
77 Participants
n=5 Participants
Sex: Female, Male
Male
23 Participants
n=5 Participants
33 Participants
n=7 Participants
56 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Asian
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=5 Participants
5 Participants
n=7 Participants
8 Participants
n=5 Participants
Race (NIH/OMB)
White
61 Participants
n=5 Participants
57 Participants
n=7 Participants
118 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Region of Enrollment
United States
68 participants
n=5 Participants
65 participants
n=7 Participants
133 participants
n=5 Participants
Type of rhinitis (nonallergic rhinitis)
39 Participants
n=5 Participants
37 Participants
n=7 Participants
76 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 90-days post treatment

Population: 1active ClariFix arm participant returned for the follow up visit, but did not complete the rTNSS

Responders are defined as participants with a 30% or greater reduction in reflective Total Nasal Symptom Score (rTNSS) relative to baseline. The active treatment will be compared with the sham treatment. The reflective Total Nasal Symptom Score (rTNSS) is a validated PRO consisting of 4 nasal symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing that are assessed over the previous 2-week period. Each symptom is rated on a scale of 0 (no symptoms) to 3 (severe symptoms) and the scores are summed to provide a total rTNSS with a possible range of 0 to 12.

Outcome measures

Outcome measures
Measure
ClariFix
n=64 Participants
Cryotherapy of the nasal passages with the ClariFix device. ClariFix cryotherapy: Bilateral freeze ablation of nasal tissue using the ClariFix device.
Sham
n=63 Participants
Sham cryotherapy of the nasal passages with the ClariFix device Sham ClariFix cryotherapy: Bilateral sham ablation procedure using the ClariFix device.
rTNSS Responder Rate
47 Participants
23 Participants

SECONDARY outcome

Timeframe: Through 12 months post treatment

Mean change from baseline in the rTNSS. The reflective Total Nasal Symptom Score (rTNSS) is a validated PRO consisting of 4 nasal symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing that are assessed over the previous 2-week period. Each symptom is rated on a scale of 0 (no symptoms) to 3 (severe symptoms) and the scores are summed to provide a total rTNSS with a possible range of 0 to 12.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 12 months post treatment

Mean change from baseline in the Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)) score. The RQLQ(S) is a validated PRO that measures functional impairments due to allergic or non-allergic rhinoconjunctivitis. The assessment consists of 28 questions related to nose symptoms, eye symptoms, non-eye/nose symptoms, sleep problems, practical problems, activity limitations, and emotional function. Each item is scored from 0 (no impairment) to 6 (severely impaired). An overall score is calculated from the mean of the 28 item responses. Domain scores are the mean of the item scores within that domain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 12 months post treatment

Percent of participants indicating satisfaction with the procedure outcome. The satisfaction questionnaire consists of 3 questions that the participant answers at each follow-up visit. The questions indicate whether the participant is satisfied with the procedure outcome, whether the participant would undergo the procedure again for similar results, and whether the participant would recommend the procedure to family or friends with a similar condition. For each item the participant indicates agreement/disagreement with each statement.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 12 months post procedure

The number of participants with one or more serious adverse events that are possibly, probably, or definitely related to the ClariFix device and/or procedure.

Outcome measures

Outcome data not reported

Adverse Events

ClariFix

Serious events: 1 serious events
Other events: 33 other events
Deaths: 33 deaths

Sham

Serious events: 1 serious events
Other events: 4 other events
Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure
ClariFix
n=68 participants at risk
Cryotherapy of the nasal passages with the ClariFix device. ClariFix cryotherapy: Bilateral freeze ablation of nasal tissue using the ClariFix device.
Sham
n=65 participants at risk
Sham cryotherapy of the nasal passages with the ClariFix device Sham ClariFix cryotherapy: Bilateral sham ablation procedure using the ClariFix device.
Psychiatric disorders
Panic Attack
1.5%
1/68 • Number of events 1 • Screening through 90 days
0.00%
0/65 • Screening through 90 days
Respiratory, thoracic and mediastinal disorders
Hemoptysis
0.00%
0/68 • Screening through 90 days
1.5%
1/65 • Number of events 1 • Screening through 90 days

Other adverse events

Other adverse events
Measure
ClariFix
n=68 participants at risk
Cryotherapy of the nasal passages with the ClariFix device. ClariFix cryotherapy: Bilateral freeze ablation of nasal tissue using the ClariFix device.
Sham
n=65 participants at risk
Sham cryotherapy of the nasal passages with the ClariFix device Sham ClariFix cryotherapy: Bilateral sham ablation procedure using the ClariFix device.
Surgical and medical procedures
Pain/discomfort at treatment site
36.8%
25/68 • Number of events 25 • Screening through 90 days
1.5%
1/65 • Number of events 1 • Screening through 90 days
General disorders
Other
11.8%
8/68 • Number of events 8 • Screening through 90 days
4.6%
3/65 • Number of events 3 • Screening through 90 days

Additional Information

Robyn Schacherer, Manager Clinical Affairs

Stryker

Phone: 763-463-7054

Results disclosure agreements

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