Back to resultsInFlux System for Nasal Breathing Improvement
Primary Purpose
Nasal Airway Obstruction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Procedure: thermal coagulation of tissue in the nasal airway
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Airway Obstruction focused on measuring nasal obstruction
Eligibility Criteria
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
Sites / Locations
- St. Elizabeth's Medical Center
- Bay Area ENT
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
InFlux System
Arm Description
Intervention: Procedure: thermal coagulation of tissue in the nasal airway
Outcomes
Primary Outcome Measures
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)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01960816
Brief Title
InFlux System for Nasal Breathing Improvement
Official Title
Pilot Study of Aerin Medical's InFlux System for Improvement in Nasal Breathing
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerin Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pilot Study of the Aerin Medical Wand used for Improvement in Nasal Breathing
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Airway Obstruction
Keywords
nasal obstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
InFlux System
Arm Type
Experimental
Arm Description
Intervention: Procedure: thermal coagulation of tissue in the nasal airway
Intervention Type
Device
Intervention Name(s)
Procedure: thermal coagulation of tissue in the nasal airway
Other Intervention Name(s)
Vivaer Stylus, Aerin Medical Wand
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Unanticipated Serious Adverse Device Effects
Description
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)
Time Frame
90 Days
Title
Technical Feasibility as Assessed by the Ability of the InFlux Device to Deliver RF Energy to Target Tissue
Description
Ability of the InFlux device to deliver RF energy at the selected power setting, and to reach and maintain the selected target temperature.
Time Frame
Procedure, up to 1 hour (average, 16 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Catalano, MD
Organizational Affiliation
Steward Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Bay Area ENT
City
Ocean Springs
State/Province
Mississippi
ZIP/Postal Code
39564
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
InFlux System for Nasal Breathing Improvement
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