InFlux System for Nasal Breathing Improvement

NCT01960816 | Completed Results

• 1 other identifier: TP026
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Nasal Airway Obstruction

Keywords

nasal obstruction

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

InFlux System

EXPERIMENTAL

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

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

Interventions

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.

Also known as: Vivaer Stylus, Aerin Medical Wand

InFlux System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with history of Chronic nasal obstruction and Poor nasal breathing

You may not qualify if:

• Patients with prior nasal history, nasal pathology, or injury, and/or other conditions that may interfere with participation in the study

Sponsors & Collaborators

• Aerin Medical: lead

Study Sites (2)

St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

Bay Area ENT

Ocean Springs, Mississippi, 39564, United States

Location

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Scott Wolf, M.D., President and Chief Medical Officer
• Organization: Aerin Medical, Inc.

scott@aerinmedical.com

650-434-3247

Study Officials

• Peter Catalano, MD

  Steward Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 11, 2013
• Study Start: September 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: April 1, 2016
• Last Updated: September 26, 2016
• Results First Posted: August 19, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)