InFlux System for Nasal Breathing Improvement
- Conditions
- Nasal Airway Obstruction
- Registration Number
- NCT01960816
- Lead Sponsor
- Aerin Medical
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- Patients with history of Chronic nasal obstruction and Poor nasal breathing
- Patients with prior nasal history, nasal pathology, or injury, and/or other conditions that may interfere with participation in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
St. Elizabeth's Medical Center
🇺🇸Boston, Massachusetts, United States
Bay Area ENT
🇺🇸Ocean Springs, Mississippi, United States