Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction
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|ClinicalTrials.gov Identifier: NCT03156270|
Recruitment Status : Completed
First Posted : May 17, 2017
Results First Posted : June 16, 2021
Last Update Posted : June 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Nasal Obstruction||Device: Vivaer Stylus||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Non-Randomized Study to Evaluate Treatment Outcome of Nasal Airway Obstruction Using the Aerin Medical Vivaer™ Stylus|
|Actual Study Start Date :||September 19, 2017|
|Actual Primary Completion Date :||July 12, 2019|
|Actual Study Completion Date :||August 6, 2019|
Experimental: Vivaer Stylus Treatment
Thermal treatment of the submucosal tissue including cartilage in the internal nasal valve area
Device: Vivaer Stylus
Stylus used to deliver low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Other Name: Aerin Medical Stylus
- Change in NOSE Score [ Time Frame: Baseline, 90 days ]
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.
- Change in VAS of Nasal Obstruction [ Time Frame: Baseline, 90 days ]
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.
- Change in Peak Nasal Inspiratory Flow [ Time Frame: Baseline, 90 days ]Peak inspiratory flow measurements of nasal physical resistance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03156270
|United States, Ohio|
|The Ohio State Eye and Ear Institute|
|Columbus, Ohio, United States, 43212|
|Principal Investigator:||Brad Otto, MD||The Ohio State Eye and Ear Institute|