Trial Outcomes & Findings for Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction (NCT NCT03156270)

Last Updated: 2021-06-16

Results Overview

Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline to 90 days post-study procedure. Improvement (90 day score - baseline score) is signified by a negative 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

20 participants

Primary outcome timeframe

Baseline, 90 days

Results posted on

2021-06-16

Participant Flow

Patients with a history of chronic nasal obstruction for at least 1 year were prospectively enrolled at this tertiary academic center.

Participant milestones

Participant milestones
Measure	Vivaer Stylus Treatment Thermal treatment of the submucosal tissue including cartilage in the internal nasal valve area Vivaer Stylus: Stylus used to deliver low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Overall Study STARTED	20
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Vivaer Stylus Treatment Thermal treatment of the submucosal tissue including cartilage in the internal nasal valve area Vivaer Stylus: Stylus used to deliver low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Overall Study Failed pre-treatment screening	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Followed Through 90 Days n=18 Participants Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment
Age, Continuous	46.4 years STANDARD_DEVIATION 17.3 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants
Race/Ethnicity, Customized White	16 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants
Nasal Obstruction Symptom Evaluation (NOSE) score	78.9 score on a scale STANDARD_DEVIATION 11.6 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 90 days

Outcome measures

Outcome measures
Measure	Subjects Followed Through 90 Days n=18 Participants Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment	Subjects Followed Through 90 Days - 90 Day Data Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment
Change in NOSE Score	-44.5 units on a scale Standard Deviation 27.0	—

PRIMARY outcome

Timeframe: Baseline, 90 days

Population: Includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment

Change in visual-analog scale (VAS) of nasal obstruction severity as perceived by the subject from baseline to 90 days post-study procedure. Improvement (90-day score - baseline score) is signified by a negative value. The visual-analog scale (VAS) of nasal obstruction is presented to the subject as a 10cm line anchored on each end by verbal descriptors: 0 = No Obstruction and 10 = Completely Obstructed. The subject is asked to place a vertical mark on the line to show the level of nasal obstruction they feel. The distance between 0 and the vertical mark made by the subject is measured and the results is expressed in centimeters. Higher scores indicate more severe obstruction.

Outcome measures

Outcome measures
Measure	Subjects Followed Through 90 Days n=18 Participants Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment	Subjects Followed Through 90 Days - 90 Day Data Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment
Change in VAS of Nasal Obstruction	-2.6 units on a scale Standard Deviation 2.2	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 90 days

Peak inspiratory flow measurements of nasal physical resistance

Outcome measures

Outcome measures
Measure	Subjects Followed Through 90 Days n=18 Participants Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment	Subjects Followed Through 90 Days - 90 Day Data n=18 Participants Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment
Change in Peak Nasal Inspiratory Flow	60.2 ml/sec Standard Deviation 34.5	72.4 ml/sec Standard Deviation 43.7

Adverse Events

Subjects Followed Through 90 Days

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Subjects Followed Through 90 Days n=18 participants at risk Patient cohort includes all subjects treated with the Vivaer Stylus who were evaluated 90 days post-treatment
Musculoskeletal and connective tissue disorders Orthopedic injury or surgery	11.1% 2/18 • Number of events 6 • From procedure through 90-day evaluation Subjects were queried for adverse events after the procedure and at the 90-day evaluation visit. Details of events were documented on a standardized case report form.
Infections and infestations Sinusitis	11.1% 2/18 • Number of events 3 • From procedure through 90-day evaluation Subjects were queried for adverse events after the procedure and at the 90-day evaluation visit. Details of events were documented on a standardized case report form.
Musculoskeletal and connective tissue disorders Dental treatments	11.1% 2/18 • Number of events 3 • From procedure through 90-day evaluation Subjects were queried for adverse events after the procedure and at the 90-day evaluation visit. Details of events were documented on a standardized case report form.
Infections and infestations Body rash	5.6% 1/18 • Number of events 1 • From procedure through 90-day evaluation Subjects were queried for adverse events after the procedure and at the 90-day evaluation visit. Details of events were documented on a standardized case report form.
General disorders Colonoscopy with polyp removal	5.6% 1/18 • Number of events 1 • From procedure through 90-day evaluation Subjects were queried for adverse events after the procedure and at the 90-day evaluation visit. Details of events were documented on a standardized case report form.
Respiratory, thoracic and mediastinal disorders Bulb on nostril with diminished airflow	5.6% 1/18 • Number of events 1 • From procedure through 90-day evaluation Subjects were queried for adverse events after the procedure and at the 90-day evaluation visit. Details of events were documented on a standardized case report form.

Additional Information

Kai Zhao, PhD.

Dept. of Otolaryngology-Head and Neck Surgery, The Ohio State University

Phone: 614-293-3857

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI/Institution will provide Sponsor with a copy of any proposed manuscripts or other material for publication thirty (30) days prior to publication for review and comment. Sponsor's comments shall be given due consideration by PI/Institution. Publication may be delayed at Sponsor's written request for a period not to exceed sixty (60) days if it contains a disclosure of an invention(s) on which either party desires to file a patent.
Publication restrictions are in place

Restriction type: OTHER