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

NCT ID: NCT03290300

Last Updated: 2024-02-15

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

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-30

Study Completion Date

2022-07-09

Brief Summary

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Evaluation of long-term (5-year) quality of life after nasal airway obstruction treatment with the Aerin Vivaer Stylus

Detailed Description

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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, 24, 36, 48 and 60 months post-procedure.

Conditions

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Nasal Obstruction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Vivaer Stylus

Intervention Type DEVICE

Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus

Interventions

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Vivaer Stylus

Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus

Intervention Type DEVICE

Other Intervention Names

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Aerin Medical Device

Eligibility Criteria

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Inclusion Criteria

* Received nasal obstruction treatment in Aerin Study TP 258

Exclusion Criteria

* Unwilling to participate in this long-term study
Minimum Eligible Age

22 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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Scott Wolf, MD

Role: STUDY_DIRECTOR

Aerin Medical

Ofer Jacobowitz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ENT and Allergy Associates, Middletown, NY

Locations

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Central California Clinical Research

Fresno, California, United States

Site Status

Colorado ENT and Allergy

Colorado Springs, Colorado, United States

Site Status

ENT and Allergy Associates, LLP

Oradell, New Jersey, United States

Site Status

ENT and Allergy Associates, LLP

Bayside, New York, United States

Site Status

ENT and Allergy Associates, LLP

Middletown, New York, United States

Site Status

ENT and Allergy Associates, LLP

New Hyde Park, New York, United States

Site Status

Piedmont Ear, Nose and Throat Associates

Winston-Salem, North Carolina, United States

Site Status

Ear, Nose and Throat Associates of Texas

McKinney, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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TP465

Identifier Type: -

Identifier Source: org_study_id

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