N/A
N=33
InFlux System for Nasal Breathing Improvement
Nasal Airway Obstruction
Bottom Line
View on ClinicalTrials.gov: NCT01960816 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Incidence of Unanticipated Serious Adverse Device Effects — 0 events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Procedure: thermal coagulation of tissue in the nasal airway (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aerin Medical
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Unanticipated Serious Adverse Device Effects |
— | — |
| PRIMARY Technical Feasibility as Assessed by the Ability of the InFlux Device to Deliver RF Energy to Target Tissue |
33 | — |
Summary
Pilot Study of the Aerin Medical Wand used for Improvement in Nasal Breathing
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01960816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.