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

NCT ID: NCT06992037

Last Updated: 2025-12-26

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

1110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-14

Study Completion Date

2025-07-21

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Nasal Airway Obstruction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Functional Rhinoplasty

Patients received a non-study/Standard of Care Functional Rhinoplasty within the past 5 years

No interventions assigned to this group

Septoplasty

Patients received a non-study/Standard of Care Septoplasty within the past 5 years

No interventions assigned to this group

Vivaer

Patients received a Vivaer procedure (radiofrequency) within the past 5 years

No interventions assigned to this group

Rhinaer

Patients received a Rhinaer procedure (radiofrequency) within the past 5 years

No interventions assigned to this group

Eligibility Criteria

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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

* Had extreme nasal pathology or a history of extreme nasal injuries.
* Had cosmetic rhinoplasty with no functional component.
Minimum Eligible Age

22 Years

Maximum Eligible Age

85 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

Locations

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Chicago Nasal & Sinus Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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CTP2144

Identifier Type: -

Identifier Source: org_study_id