Overview

This trial is active, not recruiting.

Condition nasal airway obstruction
Treatment procedure: thermal coagulation of tissue in the nasal airway
Sponsor Aerin Medical
Start date September 2013
End date January 2016
Trial size 33 participants
Trial identifier NCT01960816, TP026

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Intervention: Procedure: thermal coagulation of tissue in the nasal airway
procedure: thermal coagulation of tissue in the nasal airway Aerin Medical Wand used for treatment of nasal airway tissue
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.

Primary Outcomes

Measure
Freedom from Unanticipated Serious Adverse Device Effects
time frame: 90 Days

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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

Additional Information

Official title Pilot Study of Aerin Medical's InFlux System for Improvement in Nasal Breathing
Principal investigator Peter Catalano, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Aerin Medical.