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Completed

NCT Number: NCT01960816

InFlux System for Nasal Breathing Improvement

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

Completed

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Key information

Conditions

Nasal Airway Obstruction Airway Obstruction Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Elizabeth's Medical Center, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Procedure: thermal coagulation of tissue in the nasal airway

Device

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

Primary outcomes

  1. Incidence of Unanticipated Serious Adverse Device Effects

    Time frame: 90 Days

    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)

  2. Technical Feasibility as Assessed by the Ability of the InFlux Device to Deliver RF Energy to Target Tissue

    Time frame: Procedure, up to 1 hour (average, 16 minutes)

    Ability of the InFlux device to deliver RF energy at the selected power setting, and to reach and maintain the selected target temperature.

Sponsors and collaborators

Lead sponsor

Aerin Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 11, 2013
Registry last updated
Sep 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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