Clinical Trial: InFlux System for Nasal Breathing Improvement
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Pilot Study of Aerin Medical's InFlux System for Improvement in Nasal Breathing
Brief Summary: Pilot Study of the Aerin Medical Wand used for Improvement in Nasal Breathing
Detailed Summary: 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.
Sponsor: Aerin Medical
Current Primary Outcome:
- Incidence of Unanticipated Serious Adverse Device Effects [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Aerin Medical
Dates:
Date Received: October 8, 2013
Date Started: September 2013
Date Completion:
Last Updated: August 18, 2016
Last Verified: August 2016
