An Ambispective Registry Study Comparing Clinical Outcomes of Surgical Interventions for the Treatment of Nasal Airway Obstruction. (DUO)

Aerin Medical

Status

Completed

Conditions

Nasal Airway Obstruction

Study type

Observational

Funder types

Industry

Identifiers

NCT06992037

CTP2144

Details and patient eligibility

About

The purpose of this study is to assess and compare the clinical outcomes associated with common surgical interventions for the treatment of nasal airway obstruction (NAO).

Full description

This is a multicenter, ambispective registry study. The study will include assessment of prospective, long term outcomes by remote administration of patient reported outcome questionnaires. Participants identified in Part 1 of the study with outcomes available for at least 12 months following their surgical procedure for nasal airway obstruction will be identified by the treating physician and invited to participate in the long-term follow-up study. Participants agreeing to participate will be asked to complete a series of questions about their health experience following their surgery and will be asked to complete select health outcome questionnaires using a secure electronic survey platform.

Enrollment

1,110 patients

Sex

All

Ages

22 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 22 to 85 years old (inclusively).
Sought treatment at the clinic for nasal airway obstruction.
Had either a functional rhinoplasty or septoturbinoplasty within the time frame of January 01, 2013 to December 31, 2023 or a Temperature-Controlled Radiofrequency (TCRF) procedure between the dates of November 19, 2015 to December 31, 2023.
Has access to a mobile device, tablet, or computer with internet access and has access to an email address.
Willing and able to provide consent.
Willing and able to complete the survey, including patient-reported outcome measures.
Willing and able to comply with the patient-specific requirements outlined in the study protocol.

Exclusion criteria