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Pilot Study of the Aerin Medical Wand used for Improvement in Nasal Breathing
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InFlux System | Experimental | Intervention: Procedure: thermal coagulation of tissue in the nasal airway |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedure: thermal coagulation of tissue in the nasal airway | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 90 Days |
| 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. | Procedure, up to 1 hour (average, 16 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Catalano, MD | Steward Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Elizabeth's Medical Center | Boston | Massachusetts | 02135 | United States | ||
| Bay Area ENT |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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. | Posted | Number | events | 90 Days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory infection / symptoms of common cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Adverse events deemed not related to the investigational device or procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Wolf, M.D., President and Chief Medical Officer | Aerin Medical, Inc. | 650-434-3247 | scott@aerinmedical.com |
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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|
| Ocean Springs |
| Mississippi |
| 39564 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Nasal Obstruction Symptom Evaluation (NOSE) score | 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. | Mean | Standard Deviation | units on a scale |
|
|
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| 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. | All enrolled subjects underwent the procedure. | Posted | Number | participants | Procedure, up to 1 hour (average, 16 minutes) |
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| 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. | Subjects with 90-day follow-up data | Posted | Mean | Standard Deviation | units on a scale | 90 days |
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| 0 |
| 33 |
| 2 |
| 33 |
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| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |