Trials / Completed
CompletedNCT01960816
InFlux System for Nasal Breathing Improvement
Pilot Study of Aerin Medical's InFlux System for Improvement in Nasal Breathing
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Aerin Medical · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2016-01-01
- Completion
- 2016-04-01
- First posted
- 2013-10-11
- Last updated
- 2016-09-26
- Results posted
- 2016-08-19
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01960816. Inclusion in this directory is not an endorsement.