InFlux System for Nasal Breathing Improvement

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

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

Study Overview

• Status: Completed
• Conditions: Nasal Airway Obstruction
• Intervention / Treatment: Device: Procedure: thermal coagulation of tissue in the nasal airway

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02135
      • St. Elizabeth's Medical Center
  • Mississippi
    • Ocean Springs, Mississippi, United States, 39564
      • Bay Area ENT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: InFlux System; Intervention: Procedure: thermal coagulation of tissue in the nasal airway	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.; Other Names: Vivaer Stylus; Aerin Medical Wand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of 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
Technical Feasibility as Assessed by the Ability of the InFlux Device to Deliver RF Energy to Target Tissue	Ability of the InFlux device to deliver RF energy at the selected power setting, and to reach and maintain the selected target temperature.	Procedure, up to 1 hour (average, 16 minutes)

Collaborators and Investigators

• Sponsor: Aerin Medical
• Investigators: Principal Investigator: Peter Catalano, MD, Steward Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: October 8, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (Estimate): October 11, 2013

Study Record Updates

• Last Update Posted (Estimate): September 26, 2016
• Last Update Submitted That Met QC Criteria: August 18, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: nasal obstruction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Nose Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction
• Other Study ID Numbers: TP026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No