Quality of Life Impact of Chronic Rhinitis Treatment With Aerin Medical Device

NCT ID: NCT04684875

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-19

Study Completion Date

2022-01-01

Brief Summary

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Evaluation of long-term (2-year) quality of life and symptoms after chronic rhinitis treatment with the Aerin InSeca/RhinAer Stylus

Detailed Description

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This is a prospective, non-randomized, multicenter follow-up study to collect long-term data on a cohort of patients who participated in the Aerin Medical TP668 study, "Clinical Evaluation of Low Power Radiofrequency Energy Applied to the Posterior Nasal Nerve Area for Symptomatic Relief of Chronic Rhinitis". The study will be conducted in a maximum of 5 centers that participated and enrolled patients in the TP668 study.

Conditions

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Chronic Rhinitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Long-Term Study Subjects

All subjects who were treated with the Aerin Medical InSeca/RhinAer Stylus in the 50-subject TP668 interventional study, who consent to continue to provide quality of life data.

Radiofrequency Stylus

Intervention Type DEVICE

Low power radiofrequency energy delivered to the posterior nasal nerve area

Interventions

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Radiofrequency Stylus

Low power radiofrequency energy delivered to the posterior nasal nerve area

Intervention Type DEVICE

Other Intervention Names

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Aerin Medical Device InSeca Stylus RhinAer Stylus

Eligibility Criteria

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Inclusion Criteria

* Received treatment for chronic rhinitis in Aerin Study TP668

Exclusion Criteria

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

22 Years

Maximum Eligible Age

99 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, Inc.

Locations

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Colorado ENT and Allergy

Colorado Springs, Colorado, United States

Site Status

Advanced ENT and Allergy

New Albany, Indiana, United States

Site Status

Piedmont ENT Associates

Winston-Salem, North Carolina, United States

Site Status

Fort Worth ENT

Fort Worth, Texas, United States

Site Status

ENT and Allergy Associates of Texas

McKinney, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CTP1078

Identifier Type: -

Identifier Source: org_study_id

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