Nasal Airway Obstruction
Conditions
Keywords
nasal obstruction
Brief summary
Pilot Study of the Aerin Medical Wand used for Improvement in Nasal Breathing
Detailed description
This is a non-significant risk, prospective, non-randomized pilot study to evaluate the incidence of serious adverse events directly attributable to the Aerin Medical Wand, when used to deliver radiofrequency (RF) energy to tissues of the nasal airway for the treatment of nasal obstruction.
Interventions
DEVICEProcedure: 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.
Sponsors
Aerin Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with history of Chronic nasal obstruction and Poor nasal breathing
Exclusion criteria
* Patients with prior nasal history, nasal pathology, or injury, and/or other conditions that may interfere with participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Unanticipated Serious Adverse Device Effects | 90 Days | 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) |
| Technical Feasibility as Assessed by the Ability of the InFlux Device to Deliver RF Energy to Target Tissue | Procedure, up to 1 hour (average, 16 minutes) | Ability of the InFlux device to deliver RF energy at the selected power setting, and to reach and maintain the selected target temperature. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | InFlux System |
|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 13.1 |
| Nasal Obstruction Symptom Evaluation (NOSE) score | 58 units on a scale STANDARD_DEVIATION 21.8 |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Incidence of Unanticipated Serious Adverse Device Effects
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)
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InFlux System | Incidence of Unanticipated Serious Adverse Device Effects | 0 events |
Primary
Technical Feasibility as Assessed by the Ability of the InFlux Device to Deliver RF Energy to Target Tissue
Ability of the InFlux device to deliver RF energy at the selected power setting, and to reach and maintain the selected target temperature.
Time frame: Procedure, up to 1 hour (average, 16 minutes)
Population: All enrolled subjects underwent the procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InFlux System | Technical Feasibility as Assessed by the Ability of the InFlux Device to Deliver RF Energy to Target Tissue | 33 participants |
Post Hoc
NOSE Score at 90-day Follow-up
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.
Time frame: 90 days
Population: Subjects with 90-day follow-up data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| InFlux System | NOSE Score at 90-day Follow-up | 27 units on a scale | Standard Deviation 21.1 |