InFlux System for Nasal Breathing Improvement

Nasal Airway Obstruction Clinical Trial

Official title:

Pilot Study of Aerin Medical's InFlux System for Improvement in Nasal Breathing

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01960816
• Other study ID #: TP026
• Status: Active, not recruiting
• Phase: N/A
• First received: October 8, 2013
• Last updated: December 28, 2015
• Start date: September 2013
• Est. completion date: April 2016

Study information

• Verified date: December 2015
• Source: Aerin Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Pilot Study of the Aerin Medical Wand used for Improvement in Nasal Breathing

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airway Obstruction
• Nasal Airway Obstruction
• Nasal Obstruction

Intervention

Device:
• Procedure: thermal coagulation of tissue in the nasal airway
The Aerin Medical Wand is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway in order to shrink the enlarged tissues.

Locations

Country	Name	City	State
United States	St. Elizabeth's Medical Center	Boston	Massachusetts
United States	Bay Area ENT	Ocean Springs	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Aerin Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from 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	Yes