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Quality of Life Impact of Nasal Airway Treatment With Aerin Medical Device

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ClinicalTrials.gov Identifier: NCT03290300
Recruitment Status : Enrolling by invitation
First Posted : September 21, 2017
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Aerin Medical

Brief Summary:
Evaluation of long-term (2-year) quality of life after nasal airway obstruction treatment with the Aerin Vivaer Stylus

Condition or disease Intervention/treatment
Nasal Obstruction Device: Vivaer Stylus

Detailed Description:
This is a prospective, non-randomized, multi-center follow-up study to collect long term quality of life (QOL) data on a cohort of patients who participated in the Aerin Medical TP258 study "A Prospective, Multi-Center, Non-Randomized Study to Evaluate Treatment of Nasal Airway Obstruction Using the Aerin Medical Device". The TP258 study followed subjects out to 26 weeks post-procedure. This QOL study will collect data at 12, 18 and 24 months post-procedure.

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multi-Center, Non-Randomized Study to Evaluate the Quality of Life Impact After Treatment of Nasal Airway Obstruction Using the Aerin Medical Vivaer Stylus
Actual Study Start Date : October 30, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Choking

Group/Cohort Intervention/treatment
Long-Term Study Subjects
This cohort will consist of all subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consent to continue to provide quality of life data.
Device: Vivaer Stylus
Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus
Other Name: Aerin Medical Device




Primary Outcome Measures :
  1. Change in NOSE score [ Time Frame: 12, 18 and 24 months post-procedure ]
    Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline

  2. Quality of Life Assessment [ Time Frame: 12, 18 and 24 months post-procedure ]
    Study-specific quality of life questionnaire



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subjects in this study will all have completed participation in the TP 258 Nasal Obstruction study.
Criteria

Inclusion Criteria:

  • Received nasal obstruction treatment in Aerin Study TP 258

Exclusion Criteria:

  • Unwilling to participate in this long-term study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290300


Locations
United States, California
Central California Clinical Research
Fresno, California, United States, 93720
United States, Colorado
Colorado ENT and Allergy
Colorado Springs, Colorado, United States, 80909
United States, New Jersey
ENT and Allergy Associates, LLP
Oradell, New Jersey, United States, 07649
United States, New York
ENT and Allergy Associates, LLP
Bayside, New York, United States, 11360
ENT and Allergy Associates, LLP
Middletown, New York, United States, 10941
ENT and Allergy Associates, LLP
New Hyde Park, New York, United States, 11042
United States, North Carolina
Piedmont Ear, Nose and Throat Associates
Winston-Salem, North Carolina, United States, 27103
United States, Texas
Ear, Nose and Throat Associates of Texas
McKinney, Texas, United States, 75070
Sponsors and Collaborators
Aerin Medical
Investigators
Study Director: Scott Wolf, MD Aerin Medical
Principal Investigator: Ofer Jacobowitz, MD, PhD ENT and Allergy Associates, Middletown, NY

Responsible Party: Aerin Medical
ClinicalTrials.gov Identifier: NCT03290300     History of Changes
Other Study ID Numbers: TP465
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Aerin Medical:
Nasal valve
Nasal airway obstruction
Quality of Life

Additional relevant MeSH terms:
Airway Obstruction
Nasal Obstruction
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Nose Diseases
Otorhinolaryngologic Diseases