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

Aerin Medical

Status: Completed

Conditions: Nasal Obstruction

Treatments: Device: Vivaer Stylus

Study type: Observational

Funder types: Industry

Identifiers

NCT03290300

TP465

Details and patient eligibility

About

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

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

Enrollment: 39 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Received nasal obstruction treatment in Aerin Study TP 258

Exclusion criteria

• Unwilling to participate in this long-term study

Trial design

39 participants in 1 patient group

Long-Term Study Subjects

Description:

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.

Treatment:

Device: Vivaer Stylus