Trial Outcomes & Findings for Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis (CLARITY) (NCT NCT05324397)
NCT ID: NCT05324397
Last Updated: 2026-06-08
Results Overview
SAEs were defined per ICH-GCP (E6). This measure includes all SAEs assessed by the investigator as related to the device and/or procedure within 1 month post-procedure.
COMPLETED
NA
36 participants
1 month
2026-06-08
Participant Flow
Participants with chronic rhinitis were enrolled in a prospective, single-arm study evaluating the NEUROMARK System.
Participants who met eligibility criteria were enrolled and assigned to receive treatment with the NEUROMARK System. One participant was lost to follow-up after the 3-month visit.
Participant milestones
| Measure |
NEUROMARK Treatment
Participants with chronic rhinitis underwent treatment with the NEUROMARK System in this single-arm study.
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis (CLARITY)
Baseline characteristics by cohort
| Measure |
NEUROMARK Treatment
n=36 Participants
Participants with chronic rhinitis underwent treatment with the NEUROMARK System in this single-arm study.
|
|---|---|
|
Age, Continuous
|
62.8 Years
STANDARD_DEVIATION 14.0 • n=9 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Severity of Chronic Rhinitis
Mild
|
0 Participants
n=9 Participants
|
|
Severity of Chronic Rhinitis
Moderate
|
9 Participants
n=9 Participants
|
|
Severity of Chronic Rhinitis
Severe
|
27 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 1 monthSAEs were defined per ICH-GCP (E6). This measure includes all SAEs assessed by the investigator as related to the device and/or procedure within 1 month post-procedure.
Outcome measures
| Measure |
NEUROMARK Treatment
n=36 Participants
Participants with chronic rhinitis underwent treatment with the NEUROMARK System in this single-arm study.
|
|---|---|
|
Number of Participants With Device- or Procedure-related Serious Adverse Events (SAEs) Within 1 Month
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThe Visual Analog Scale Nasal Symptom Score (VAS NSS) is a patient-reported outcome measure of nasal symptom severity. Each symptom item is scored on a scale of 0 to 10, where 0 indicates no symptoms and 10 indicates the worst possible symptoms; higher scores indicate worse outcomes. This measure reports the mean change from baseline to 3 months in VAS NSS for \[rhinorrhea / nasal congestion\]. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
NEUROMARK Treatment
n=36 Participants
Participants with chronic rhinitis underwent treatment with the NEUROMARK System in this single-arm study.
|
|---|---|
|
Mean Change From Baseline in VAS Nasal Symptom Score (NSS) for Rhinorrhea at 3 Months
|
-4.09 Score
Standard Deviation 3.50
|
PRIMARY outcome
Timeframe: 3 monthsThe Visual Analog Scale Nasal Symptom Score (VAS NSS) is a patient-reported outcome measure of nasal symptom severity. Each symptom item is scored on a scale of 0 to 10, where 0 indicates no symptoms and 10 indicates the worst possible symptoms; higher scores indicate worse outcomes. This measure reports the mean change from baseline to 3 months in VAS NSS for \[rhinorrhea / nasal congestion\]. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
NEUROMARK Treatment
n=36 Participants
Participants with chronic rhinitis underwent treatment with the NEUROMARK System in this single-arm study.
|
|---|---|
|
Mean Change From Baseline in VAS Nasal Symptom Score (NSS) for Nasal Congestion at 3 Months
|
-3.86 Score
Standard Deviation 2.18
|
Adverse Events
NEUROMARK Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NEUROMARK Treatment
n=36 participants at risk
Participants with chronic rhinitis underwent treatment with the NEUROMARK System in this single-arm study.
|
|---|---|
|
General disorders
Pain/discomfort
|
2.8%
1/36 • from enrollment until end of follow-up, 12 months
|
|
Infections and infestations
Sinus Infection
|
2.8%
1/36 • from enrollment until end of follow-up, 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place