Trial Outcomes & Findings for InFlux System for Nasal Breathing Improvement (NCT NCT01960816)

NCT ID: NCT01960816

Last Updated: 2016-09-26

Results Overview

The study will be considered to have met its primary safety endpoint if no subject experiences an unanticipated serious adverse device effect (USADE defined as any serious adverse effect caused by, or associated with, the investigational device, that was not previously identified in nature, severity, or degree of incidence in the protocol)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: 90 Days
• Results posted on: 2016-09-26

Participant Flow

Participant milestones

Measure	InFlux System Intervention: Procedure: thermal coagulation of tissue in the nasal airway Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage.
Overall Study STARTED	33
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	InFlux System Intervention: Procedure: thermal coagulation of tissue in the nasal airway Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage.
Overall Study Lost to Follow-up	1

Baseline Characteristics

InFlux System for Nasal Breathing Improvement

Baseline characteristics by cohort

Measure	InFlux System n=33 Participants Intervention: Procedure: thermal coagulation of tissue in the nasal airway Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage.
Age, Continuous	51 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants
Nasal Obstruction Symptom Evaluation (NOSE) score	58 units on a scale STANDARD_DEVIATION 21.8 • n=5 Participants

PRIMARY outcome

Timeframe: 90 Days

Population: One subject was lost-to-follow-up prior to the 90-day follow-up visit. Therefore, 32 subjects were available for analysis at the 90-day time point.

The study will be considered to have met its primary safety endpoint if no subject experiences an unanticipated serious adverse device effect (USADE defined as any serious adverse effect caused by, or associated with, the investigational device, that was not previously identified in nature, severity, or degree of incidence in the protocol)

Outcome measures

Measure	InFlux System n=32 Participants Intervention: Procedure: thermal coagulation of tissue in the nasal airway Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage.
Incidence of Unanticipated Serious Adverse Device Effects	0 events

PRIMARY outcome

Timeframe: Procedure, up to 1 hour (average, 16 minutes)

Population: All enrolled subjects underwent the procedure.

Ability of the InFlux device to deliver RF energy at the selected power setting, and to reach and maintain the selected target temperature.

Outcome measures

Measure	InFlux System n=33 Participants Intervention: Procedure: thermal coagulation of tissue in the nasal airway Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage.
Technical Feasibility as Assessed by the Ability of the InFlux Device to Deliver RF Energy to Target Tissue	33 participants

POST_HOC outcome

Timeframe: 90 days

Population: Subjects with 90-day follow-up data

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. Each subject's NOSE score at the 90-day follow-up was compared to that subject's baseline NOSE score to determine change in nasal obstruction symptoms.

Outcome measures

Measure	InFlux System n=32 Participants Intervention: Procedure: thermal coagulation of tissue in the nasal airway Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage.
NOSE Score at 90-day Follow-up	27 units on a scale Standard Deviation 21.1

Adverse Events

InFlux System

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	InFlux System n=33 participants at risk Intervention: Procedure: thermal coagulation of tissue in the nasal airway Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection / symptoms of common cold	6.1% 2/33 • Number of events 2

Additional Information

Scott Wolf, M.D., President and Chief Medical Officer

Aerin Medical, Inc.

Phone: 650-434-3247

Email: scott@aerinmedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60