Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Rhinitis

Keywords

Chronic rhinitisPosterior nasal nerveQuality of life

Outcome Measures

Primary Outcomes (1)

Change from Baseline rTNSS
Mean change in reflective Total Nasal Symptom Score (rTNSS) from baseline. The TNSS is an instrument used to collect patient self-rated severity of rhinorrhea, nasal congestion, nasal itching and sneezing. In this study, a reflective score will be collected, in which the subject will be asked to evaluate symptom severity over the preceding 12 hours. Symptom severity is rated on a 4-point scale of 0 (absent symptoms), 1 (mild symptoms), 2 (moderate symptoms, or 3 (severe symptoms), with the total score therefore ranging from 0 to 12. A negative change reported for the change from baseline indicates an improved outcome.
24 months

Study Arms (1)

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.

Device: Radiofrequency Stylus

Interventions

Radiofrequency StylusDevice

Low power radiofrequency energy delivered to the posterior nasal nerve area

Also known as: Aerin Medical Device, InSeca Stylus, RhinAer Stylus

Long-Term Study Subjects

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age22 Years - 99 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Subjects who completed the 52-week follow-up visit of Aerin Study TP668 and consent to provide long-term quality of life and symptom information.

You may qualify if:

Received treatment for chronic rhinitis in Aerin Study TP668

You may not qualify if:

Sponsors & Collaborators

Aerin Medical
Industrylead

Study Sites (5)

Colorado ENT and Allergy

Colorado Springs, Colorado, 80909, United States

Advanced ENT and Allergy

New Albany, Indiana, 47150, United States

Piedmont ENT Associates

Winston-Salem, North Carolina, 27103, United States

Fort Worth ENT

Fort Worth, Texas, 76109, United States

ENT and Allergy Associates of Texas

McKinney, Texas, 75070, United States

Study Officials

Scott Wolf, MD
Aerin Medical, Inc.
STUDY DIRECTOR

Enrollment

45 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 22, 2020

First Posted

December 28, 2020

Study Start

November 19, 2020

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Long-Term Study Subjects

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (5)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Long-Term Study Subjects

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (5)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations