Trial Outcomes & Findings for Multi-Treatment PNN Modulation for Chronic Rhinitis (NCT NCT03791489)

NCT ID: NCT03791489

Last Updated: 2020-07-24

Results Overview

The outcome measure is the number of participants experiencing 1 or more SAEs/SADEs.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

Study duration (90-days)

Results posted on

2020-07-24

Participant Flow

Participant milestones

Participant milestones
Measure	Active Treatment ClariFix: 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.
30 Days STARTED	30
30 Days COMPLETED	30
30 Days NOT COMPLETED	0
90 Days (Primary Endpoint) STARTED	30
90 Days (Primary Endpoint) COMPLETED	30
90 Days (Primary Endpoint) NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multi-Treatment PNN Modulation for Chronic Rhinitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Treatment n=30 Participants ClariFix: 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.
Age, Continuous	60.0 years STANDARD_DEVIATION 15.8 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	0 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants
Number with allergic rhinitis	11 Participants n=5 Participants
Number with nonallergic rhinitis	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: Study duration (90-days)

Population: All enrolled participants

The outcome measure is the number of participants experiencing 1 or more SAEs/SADEs.

Outcome measures

Outcome measures
Measure	Active Treatment n=30 Participants ClariFix: 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.
Number of Participants With Procedure-related Serious Adverse Events (SAEs) and/or Serious Adverse Device Effects (SADE)	0 Participants

SECONDARY outcome

Timeframe: Day of treatment during procedure and for up to 1 hour post procedure

Population: All enrolled participants

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).

Outcome measures

Outcome measures
Measure	Active Treatment n=30 Participants ClariFix: 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.
Pain Scores During treatment	1.0 score on a scale Standard Deviation 1.95
Pain Scores Post treatment	4.1 score on a scale Standard Deviation 3.87

SECONDARY outcome

Timeframe: 30 and 90 days after treatment

Population: All enrolled participants with the applicable follow-up visit.

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.

Outcome measures

Outcome measures
Measure	Active Treatment n=30 Participants ClariFix: 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.
Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS) 30-day follow-up	-3.5 score on a scale Interval -5.0 to -2.0
Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS) 90-day follow-up	-4.0 score on a scale Interval -6.0 to -1.0

SECONDARY outcome

Timeframe: 30 and 90 days after treatment

Population: All enrolled participants with the applicable follow-up visit.

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.

Outcome measures

Outcome measures
Measure	Active Treatment n=30 Participants ClariFix: 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.
Change From Baseline in the Overall Nasal Obstruction Symptom Evaluation (NOSE) Score 30-day follow-up	-19.0 score on a scale Standard Deviation 28.3
Change From Baseline in the Overall Nasal Obstruction Symptom Evaluation (NOSE) Score 90-day follow-up	-31.4 score on a scale Standard Deviation 34.4

Adverse Events

Active Treatment

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active Treatment n=30 participants at risk ClariFix: 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.
Nervous system disorders Headache	40.0% 12/30 • Number of events 12 • Adverse events were collected through the study duration of 90 day after the ClariFix procedure.
Injury, poisoning and procedural complications Postprocedure pain/discomfort	33.3% 10/30 • Number of events 10 • Adverse events were collected through the study duration of 90 day after the ClariFix procedure.
Injury, poisoning and procedural complications Palate numbness	26.7% 8/30 • Number of events 8 • Adverse events were collected through the study duration of 90 day after the ClariFix procedure.
General disorders Nasal discharge	6.7% 2/30 • Number of events 2 • Adverse events were collected through the study duration of 90 day after the ClariFix procedure.

Additional Information

Pr. Clinical Research & Publications Manager

Stryker ENT

Phone: 763-463-1598

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60