InFlux System for Nasal Breathing Improvement

Aerin Medical

Status: Completed

Conditions: Nasal Airway Obstruction

Treatments: Device: Procedure: thermal coagulation of tissue in the nasal airway

Study type: Interventional

Funder types: Industry

Identifiers

NCT01960816

TP026

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

InFlux System

Experimental group

Description:

Intervention: Procedure: thermal coagulation of tissue in the nasal airway

Treatment:

Device: Procedure: thermal coagulation of tissue in the nasal airway