Trial Outcomes & Findings for Treatment of Nasal Airway Obstruction Using the Aerin Medical Device (NCT NCT02914236)

Last Updated: 2019-05-21

Results Overview

Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline to 26 weeks post-study procedure. Improvement (baseline score - 26-week score) is signified by a positive value. The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific health status outcomes instrument, used to assess severity of nasal obstruction symptoms. Score ranges from 0 to 100. Higher scores indicate increased symptoms/symptom severity.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Baseline, 26 weeks

Results posted on

2019-05-21

Participant Flow

Patients in the specialist's clinic with symptoms associated with nasal airway obstruction were approached for possible participation. Following completion of the informed consent process, baseline evaluation was conducted.

Four potential subjects failed to meet one or more of the inclusion/exclusion criteria. One additional subject met all criteria, but other health issues precluded commitment to the study.

Participant milestones

Participant milestones
Measure	Vivaer Stylus Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Overall Study STARTED	50
Overall Study 4-week Follow-up Visit	50
Overall Study 12-week Follow-up Visit	50
Overall Study 26-week Follow-up Visit	49
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Vivaer Stylus Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Overall Study Lost to Follow-up	1

Baseline Characteristics

Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vivaer Stylus n=50 Participants Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Age, Continuous	50.9 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 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	0 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	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants
Nasal Obstruction Symptom Evaluation (NOSE) score	79.9 units on a scale STANDARD_DEVIATION 10.8 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 26 weeks

Population: Does not include subject lost-to-follow-up prior to the 26-week follow-up visit

Outcome measures

Outcome measures
Measure	Vivaer Stylus n=49 Participants Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Improvement in NOSE Score	54.8 units on a scale Standard Deviation 21.9

SECONDARY outcome

Timeframe: Baseline, 26 weeks

Population: Does not include subject lost-to-follow-up prior to 26-week follow-up

Percent subjects who are responders to therapy; responder is defined as a treated subject who experiences at least a 15-point improvement in NOSE score from baseline to 26 weeks post treatment.

Outcome measures

Outcome measures
Measure	Vivaer Stylus n=49 Participants Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
NOSE Responder Rate	93.9 percentage of treated subjects Interval 83.5 to 97.9

SECONDARY outcome

Timeframe: Baseline through 26 weeks

Population: All treated subjects

Characterization of the type and frequency of treatment-related adverse events reported during or following the study procedure, throughout the follow-up period.

Outcome measures

Outcome measures
Measure	Vivaer Stylus n=50 Participants Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Percentage of Participants With Treatment-Related Adverse Events (Safety)	20 percentage of subjects having an event

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately after study procedure, 4-weeks

Population: All treated subjects were asked to rate the pain level in each of their nostrils immediately following the treatment procedure and at the 4-week follow-up visit.

Procedure-related pain as reported by the subject using a 100mm Visual Analog Scale (VAS), immediately post-procedure and at the 4-week follow-up visit. Higher scores indicate more severe pain. The Pain VAS is presented to the subject as a 100mm line anchored on each end by verbal descriptors: 0 = no pain and 100 = worse pain imaginable. The distance between 0 and the vertical mark made by the subject is measured and the result is expressed in millimeters.

Outcome measures

Outcome measures
Measure	Vivaer Stylus n=99 Nostrils Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Subject-reported Pain Related to the Study Procedure, as Reported on 100mm Visual Analog Scale Post-Procedure, left nostril	28.7 units on a scale Standard Deviation 26.0
Subject-reported Pain Related to the Study Procedure, as Reported on 100mm Visual Analog Scale Post-Procedure, right nostril	26.9 units on a scale Standard Deviation 23.9
Subject-reported Pain Related to the Study Procedure, as Reported on 100mm Visual Analog Scale 4-week visit, left nostril	8.9 units on a scale Standard Deviation 16.0
Subject-reported Pain Related to the Study Procedure, as Reported on 100mm Visual Analog Scale 4-week visit, right nostril	8.7 units on a scale Standard Deviation 14.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Population: Does not include subject lost-to-follow-up prior to 26-week follow-up visit

Study-specific survey to assess patient satisfaction with the discomfort of the procedure and recovery period, as well as their perceived results. The survey included 5 questions related to tolerability of the procedure, ease of recovery, change in breathing, satisfaction with treatment, and willingness to recommend treatment. Each question was scored on a 10-point scale, with 1 indicating the most negative response to the question (e.g., "very bad", "much worse", or "very dissatisfied") and 10 indicating the most favorable rating (e.g., "hardly noticeable", "much better", or "very satisfied"). Each question was individually scored and reported.

Outcome measures

Outcome measures
Measure	Vivaer Stylus n=49 Participants Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Subject Satisfaction Q1 - Procedure tolerability	7.3 units on a scale Standard Deviation 2.4
Subject Satisfaction Q2 - Ease of recovery	8.3 units on a scale Standard Deviation 1.7
Subject Satisfaction Q3 - Breathing through nose	8.3 units on a scale Standard Deviation 1.8
Subject Satisfaction Q4 - Satisfaction with treatment	8.4 units on a scale Standard Deviation 2.1
Subject Satisfaction Q5 - Likely to recommend to others	8.7 units on a scale Standard Deviation 2.1

Adverse Events

Vivaer Stylus

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vivaer Stylus n=50 participants at risk Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Gastrointestinal disorders Appendicitis	2.0% 1/50 • Number of events 1 • From procedure through 26-week follow-up visit All subjects were queried for adverse events after the procedure and at each follow-up visit. Details of events were documented on a standardized case report form. Anticipated observations in the treatment area (such as swelling, redness, or crusting related to the treatment of tissue with radiofrequency energy) were not considered adverse events unless they required mitigation or were greater in severity, duration or degree of incidence than expected.
Nervous system disorders Balance disorder	2.0% 1/50 • Number of events 1 • From procedure through 26-week follow-up visit All subjects were queried for adverse events after the procedure and at each follow-up visit. Details of events were documented on a standardized case report form. Anticipated observations in the treatment area (such as swelling, redness, or crusting related to the treatment of tissue with radiofrequency energy) were not considered adverse events unless they required mitigation or were greater in severity, duration or degree of incidence than expected.

Other adverse events

Other adverse events
Measure	Vivaer Stylus n=50 participants at risk Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area Vivaer Stylus: Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Infections and infestations nasopharyngitis	6.0% 3/50 • Number of events 3 • From procedure through 26-week follow-up visit All subjects were queried for adverse events after the procedure and at each follow-up visit. Details of events were documented on a standardized case report form. Anticipated observations in the treatment area (such as swelling, redness, or crusting related to the treatment of tissue with radiofrequency energy) were not considered adverse events unless they required mitigation or were greater in severity, duration or degree of incidence than expected.
Infections and infestations Upper respiratory tract infection	6.0% 3/50 • Number of events 3 • From procedure through 26-week follow-up visit All subjects were queried for adverse events after the procedure and at each follow-up visit. Details of events were documented on a standardized case report form. Anticipated observations in the treatment area (such as swelling, redness, or crusting related to the treatment of tissue with radiofrequency energy) were not considered adverse events unless they required mitigation or were greater in severity, duration or degree of incidence than expected.
Respiratory, thoracic and mediastinal disorders Nasal congestion	8.0% 4/50 • Number of events 4 • From procedure through 26-week follow-up visit All subjects were queried for adverse events after the procedure and at each follow-up visit. Details of events were documented on a standardized case report form. Anticipated observations in the treatment area (such as swelling, redness, or crusting related to the treatment of tissue with radiofrequency energy) were not considered adverse events unless they required mitigation or were greater in severity, duration or degree of incidence than expected.
Respiratory, thoracic and mediastinal disorders Nasal edema	10.0% 5/50 • Number of events 5 • From procedure through 26-week follow-up visit All subjects were queried for adverse events after the procedure and at each follow-up visit. Details of events were documented on a standardized case report form. Anticipated observations in the treatment area (such as swelling, redness, or crusting related to the treatment of tissue with radiofrequency energy) were not considered adverse events unless they required mitigation or were greater in severity, duration or degree of incidence than expected.
Respiratory, thoracic and mediastinal disorders Sinusitis	4.0% 2/50 • Number of events 2 • From procedure through 26-week follow-up visit All subjects were queried for adverse events after the procedure and at each follow-up visit. Details of events were documented on a standardized case report form. Anticipated observations in the treatment area (such as swelling, redness, or crusting related to the treatment of tissue with radiofrequency energy) were not considered adverse events unless they required mitigation or were greater in severity, duration or degree of incidence than expected.
Respiratory, thoracic and mediastinal disorders Rhinalgia	4.0% 2/50 • Number of events 3 • From procedure through 26-week follow-up visit All subjects were queried for adverse events after the procedure and at each follow-up visit. Details of events were documented on a standardized case report form. Anticipated observations in the treatment area (such as swelling, redness, or crusting related to the treatment of tissue with radiofrequency energy) were not considered adverse events unless they required mitigation or were greater in severity, duration or degree of incidence than expected.
Nervous system disorders Presyncope	4.0% 2/50 • Number of events 2 • From procedure through 26-week follow-up visit All subjects were queried for adverse events after the procedure and at each follow-up visit. Details of events were documented on a standardized case report form. Anticipated observations in the treatment area (such as swelling, redness, or crusting related to the treatment of tissue with radiofrequency energy) were not considered adverse events unless they required mitigation or were greater in severity, duration or degree of incidence than expected.

Additional Information

Scott Wolf, M.D., Chief Medical Officer

Aerin Medical, Inc.

Phone: 650-597-0111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee First publication of study results shall be made in conjunction with the results from all clinical study centers participating in the multicenter study. If results of the multi-center study have not been published in full within 18 months after completion of the study, investigator shall be free to publish results. Investigator agrees to submit all proposed publications to the sponsor at least 60 days prior submission; the company has the right to comment.
Publication restrictions are in place

Restriction type: OTHER