InFlux System for Nasal Breathing Improvement

NCT ID: NCT01960816

Last Updated: 2016-09-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Nasal Airway Obstruction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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InFlux System

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

Group Type EXPERIMENTAL

Procedure: thermal coagulation of tissue in the nasal airway

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Vivaer Stylus Aerin Medical Wand

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aerin Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Catalano, MD

Role: PRINCIPAL_INVESTIGATOR

Steward Hospital

Locations

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St. Elizabeth's Medical Center

Boston, Massachusetts, United States

Site Status

Bay Area ENT

Ocean Springs, Mississippi, United States

Site Status

Countries

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United States

Other Identifiers

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TP026

Identifier Type: -

Identifier Source: org_study_id

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